All Things Quality, with Kimberly Wallbank

Dori welcomes our latest guest, Kimberly Wallbank, to talk all things Quality in FDA regulated organizations. Together they discuss everything from identifying and mitigating risk, supply chain complexities, why cross-team collaboration is important, improving Quality systems to better meet objectives of delivering safe and effective product more efficiently, and everything in between. Kimberly truly brought a wealth of insights to our audience and this is a great conversation for anyone in the industry to listen in on.

Kimberly is the Managing Owner and Principal Consultant for Quality Systems Services, LLC. With more than 25 years in the industry, she has diverse experience and expertise in assisting pharmaceutical, biotechnology and medical device companies achieve compliance with FDA, EMEA, ISO and other recognized standards.

She applies this experience by collaborating with companies to establish, maintain, and improve their quality systems so they can provide world class healthcare products.  As an industry leader, she navigates the complexities of FDA compliance while maintaining the most efficient processes for their unique business needs and is passionate about developing ways to infuse quality roles into STEM education.

Follow Kimberly on LinkedIn here.

*Disclaimer: Podcast guest participated in the podcast as an individual subject matter expert and contributor. The views and opinions they share are not necessarily shared by their employer. Nor should any reference to specific products or services be interpreted as commercial endorsements by their current employer.

This is a joint Podcast production of ProcellaRX and KENX

Transcript

Dori Gonzalez-Acevedo: 0:00

Hey Kimberly, how are you today?

Kimberly Wallbank: 0:02

I'm doing well. Thank you. Dori, how are you?

Dori Gonzalez-Acevedo: 0:05

Good. Well, thanks for joining me on another episode of women leading validation. I'm super excited to have you here today.

Kimberly Wallbank: 0:12

I'm happy to be here. Thank you.

Dori Gonzalez-Acevedo: 0:15

We are I am live in DC. Where are you calling in from?

Kimberly Wallbank: 0:19

I am calling in from New Rochelle, New York. So in case you're not sure where that is? I am just north of the Bronx in Westchester County.

Dori Gonzalez-Acevedo: 0:27

All right. All right. So so a nice spring day there hopefully for you. Cool. So I we got introduced via mutual friend from from connects, right. And I would love for you to share with the audience about who you are, and like what you do in this space of quality and validation, because I think it's really interesting for our folks to hear about. Sure, I'd

Kimberly Wallbank: 0:51

be happy to. So what I do is I'm an independent consultant, I am the Managing owner of quality systems services. What I do is I help pharmaceutical and medical device companies implement, revise, recreate or even remediate their quality systems. So there's two different venues that happen. One is the proactive way, where a company says, Hey, I think I have an issue, you know, with my training program, my complaint handling my deviation, system, supplier qualification, please come help me figure this out, or there's a new regulation they need to meet because they're expanding their business. So help me figure this out, you know, come collaborate with me to do this. The other way is the non proactive retroactive where the FDA EMA Health Canada has come in, has done an inspection and said you have issues whether it's you know, and they get a 43, sometimes a warning letter, or heaven forbid, a consent decree. And some I then come in to help them. And in some cases, the agencies will actually ask for a third party. And in those cases, I would be the third party interim control.

Dori Gonzalez-Acevedo: 2:17

So your cleaner upper sounds like and whether that comes proactively or reactionary is is you you clean up some messes, which potentially could help everybody out, right. And also, what I'm also hearing you're saying is, it's much better to be proactive in these in these areas rather than reactionary.

Kimberly Wallbank: 2:42

Absolutely. And for me, it's actually more fun, because I'm working with people who want to collaborate who are doing it, taking the initiative to do so. My clients who have been on the other side, they've been great, too. But there's this tension of the scary FDA arm, please help me get out of this. So the let's take a deep breath and figure things out and make sure we're taking time do the right thing sometimes can't happen on that end, because the FDA has put a time limit on it.

Dori Gonzalez-Acevedo: 3:17

Yeah, yeah, I hear ya, I hear that. The fear of the fear factor in any transformational changes is often the thing that I find that folks hold back on across the board, right? it paralyzes folks and not able to move and make decisions or thoughtful decisions like you're mentioning.

Kimberly Wallbank: 3:35

No, absolutely. And one of the things they don't think about, and you'll hear a lot of other industry people talk about this, too, is the cost of quality. And so everyone thinks of it as this expense. So you're you know, other groups, non non usually QA folks will talk about the cost of quality, this is just an added expense added red tape, when if you think about it more of the reducing the cost of having to rework recall. Having to revise you know, it will add up further. I mean, you can go to any conference, where they're talking about quality, and they'll talk about the dollars and cents of it's cheaper to fix the problem ahead of time than it is to deal with the fines. Yep,

Dori Gonzalez-Acevedo: 4:33

absolutely. So Kimberly, tell us a little bit about how you even came to be doing what you're doing today. I can imagine you dreamed as a little girl to become this quality person.

Kimberly Wallbank: 4:45

No, I did not. I did not think about in my bedroom dreaming about quality assurance. I didn't even know what that was. I was always interested in science. And even through high school I was thinking about medical school. and went away to college. And I love the science. But the whole pre med track was just getting a little overwhelming, a little too much stress for me. But I really did love the science. So while I was working through my undergrad, took the sciences love the experiments love the theory of it. And it was like, Oh my God, what do I do for a career? Because at the time, we, you know, back in the 90s, it was if you got a biology degree like I did, you were going to medical school, or you're going to graduate school to become a professor or some fancy research doctor, research scientist. So I ended up taking a job at Abbott Laboratories, which was the best first job I think anyone in the science field could ever have. I was in diagnostics. So as the medical device area, where I did manufacturing, quality control, process validation, I wrote standard operating procedures, it was this jack of all trades type of get your feet wet roll. So after, but then what was also great about Abbott was I moved from there to actually working on some remediation things for their quality system. And then I did get to go into r&d. Because at the time, it was like, this is kind of what I want to do. But I wasn't ready for grad school. Loved it. But I just didn't see the graduate program path for me at the time. So I ended up leaving Abbott and going to wioth, where I, again, worked in compliance and worked my way up to quality and gotten MBA along the way, because one of the things I figured I was missing was those soft business skills. So I had these hardcore science skills, but I was having some difficulties with managing projects, with working through timelines, setting up timelines, you know, things that you would think about if you had a business degree. So one of my favorite jobs was working as the Quality Assurance Manager for lab validations, I had a great team. We, we did everything from proving validation and maintenance documents for everything in the laboratories, from, you know, balances all the way to the H vac system to the computer systems. So it was very much an integrated approach. We took in a very collaborative approach not only within our team, but also with the laboratories.

Dori Gonzalez-Acevedo: 7:51

And also hands on to Yes,

Kimberly Wallbank: 7:53

yes, very hands on. And I put my MBA two skills in that job because unlike the other managers, I didn't have one customer. I had five, you know, I had five different directors I had to support. So I had to come up with things like special scheduling meetings, where I would have all these directors show up so they could understand of, you know, if Micro has a priority in chemistry as a priority and biochemistry as a priority, we need to figure out from a business perspective, which is the priority because again, I only had so many reviewers and approvers to do the work. So it I mean, it was very interesting, very exciting. One of the favorite things I did in that was developed my team. In fact, I occasionally follow them on LinkedIn and seeing where they are, I mean, ones I believe now a vice president. Another one is she was a temp for me. I had some fortunately able to bring some temps on and she was absolutely incredible. In fact, I actually got her hired to a different department. And they said, and they actually asked me like, why are you getting rid of her? I said, I'm not trying to get rid of her. This is her skills fit you better. And that's what she wants. Not what I you know, I mean, yeah, I could still use her but I was thinking about her future. And now I think she owns her own company. If I remember correctly. I haven't followed her in about a few months. But yes, she is inventing things and running her own company now which is fantastic.

Dori Gonzalez-Acevedo: 9:38

That's very cool. So um, a couple of things I hear what you're saying I'm interested in to learn more about is what do you think are some of those skills that you need in order to do quality and compliance and in this new, you know, in the way that you're talking about proactive hands on, really, you know, and elevating the output. Right? It sounds like you built a team. Previously right to do some of that, what are some of the skills that you think that are critical for that?

Kimberly Wallbank: 10:10

I, there's a lot of soft skills. One of the things, I find that listening, active listening is very important. I, one of the things I do with my clients is I use them to, to get information about their company and their systems before I even start suggesting changes. Some of them get a little frustrated at first, they're like, I just need you to fix it. It's like,

Dori Gonzalez-Acevedo: 10:39

so it's interesting, I experienced that same thing. So like, like having that slow conversation is super important in order to get to the next stage, but folks are hesitant on that. What do you what do you think that's about?

Kimberly Wallbank: 10:53

Well, a lot of times, it's, they just want it done. They just want it done. And they see you as a cost, which I am. But I like to think of my services as more of an investment for them, as opposed to an expense. And as someone who has dealt with consultants coming in and fixing problems, I, you want that consultant to ask the questions. First, I've seen consultants come in back way back when just sit in a corner and just write SOPs. And next thing, you know, you're being forced to follow them. And they are so convoluted. In order to follow them, you need to double the size of your team. It's adding to your timeline, adding to the cost of the product. And we all know how much medications tasks nowadays. So you're just adding to that cost. So I found that if I did not want to be that kind of consultants, so I wanted to understand your current process, your current organization, so I can help you put the right fixes in. In fact, a lot of times I asked to do a gap assessment first, just to kind of see where the weaknesses are, the holes are, because some people, you know, I get cold call saying I I'm a CMO and my, I sell products to people who are using our products for phase three, but they're going to commercial and now they're asking me for all this information. So I think I need to have a ditional ISO requirements post to ISO 9000. No sick Well, yeah, you probably need 1345 for medical device, that's fine. But they're like, Okay, so just write procedures for me, how much is that going to cost? And it's like, well, hold on. There were elements of 9000 that are in 1345.

Dori Gonzalez-Acevedo: 13:04

Right? So the whole thing over for

Kimberly Wallbank: 13:06

a extra fee. Let's figure out what those holes are. Because it could be based on your procedures. And again, have at this point, I haven't even seen the procedures they had right. It may be some minor tweaks, you don't need brand new SOPs, you know, or you may need one new SOP because you weren't thinking about incoming quality, for example,

Dori Gonzalez-Acevedo: 13:30

right? Or you might need to slash your existing stuff because it didn't make operational efficiencies. Yeah, I think that there's an I, again, I think you and I are very similar in mindset in trying to educate and elevate the conversation as quickly as possible, rather than waiting for the downstream unintended consequences of putting poor procedures in place or not well thought out procedures, not necessarily poor procedure, but not well thought out, not holistic, not integrated, or understanding the connections between business lines and roles and responsibilities and who's doing what and all those sorts of things which add cost for variety things, not just the the SOPs that are written and the the external resources present, you know, potentially to write those, but it's following those, it's training for those. It's then the uptake of maintaining that poor or misguided process along the ways, potentially with also tools to perpetuate those bad processes.

Kimberly Wallbank: 14:40

Absolutely. And one of the things I try to share with these clients, these potential clients is that this is your system, whatever I help you fix you, you own. You're the one who's going to have to defend it in an inspection or an audit. And let's

Dori Gonzalez-Acevedo: 14:58

be clear about that because when you You're talking about system, you're talking about your their quality management system, which is a combination of not only their policies and procedures, but then the extension of which the people that do that thing. And then the applications that support that and all of that. So it's much, much bigger, much, much broader, and, and typically is used across the entire organization.

Kimberly Wallbank: 15:24

Absolutely. And actually, I just, I just recently got a mentor for myself to help me. Because obviously, I admit, I don't know everything. And so I've been working with her on, you know, not only just how to grow my business, but how to convey what I do, because I am absolutely terrible at saying, Look at me, look at me, I can do this. And so I started writing a blog, which first came out this month, and what you just touched on about the whole process and how, you know, it's just bigger than just the SOPs and quality. My blog piece was on a sweater I just finished knitting. So I knit as a hobby, it's one of my favorite things to do. You know, the, the aspects of helping you quiet your mind helping, you know, ease stress is all true. And but this particular sweater I just finished was my first sweater where I had to sew in actual sleeves. And I go through in the blog piece, which is on my website of how frustrating it was trying to figure out how to do it. And then finding the right expert to help me. And and I've gotten some pretty interesting comments about it, because I like this is well, first of all, they all found it funny. And too, it's just talks about how things are linked together. Like I could have just left the sleeves off, but then I would have had some were looking poncho that was very expensive.

Dori Gonzalez-Acevedo: 17:11

Yes, you could have, huh? Yeah, the inter interconnectedness of all of us is really super important. And one of the things that I've, you know, as this industry has shifted, and as the relationships between contractors, consultants, vendors, you know, companies and sponsors, those lines are changing, right, and whose role and what responsibility each others are helping to fulfill has shifted right from when we when you and I both started right to where we are today. And it's continuing to change as, as, as it's gotten more just more complex, right, like, there's just more asks, the products that our sponsors are making are more complex, they're more integrated with different parts of different species, right. So you might have those, you know, software embedded as a medical device, where you have software and a medical device, and maybe potentially even having a drug in there as well, right. And so there's not one single source of ownership. It's a collaborative network that creates these products that we have today. And so that takes a more complicated system or team in order to get to a, an operational quality managed operation. And then think about how many different parts of the supply chain are all connected, all those different quality systems are connected and impact one another. And there needs to be very clear understanding between all of those parties of who's doing what.

Kimberly Wallbank: 18:57

No, absolutely. And because I've had been working with some clients lately who are working in combination products, and they're doing the right thing of hire, if they're a drug company, they're hiring some medical device, folks, if their medical device folks are hiring the drug, folks, if it's a drug and medical device combination product, the key that they're having some difficulties with is integrating those two teams together, they tend to put up this firewall between them and try to almost imaginarily split the product. And it's like, but you need to work together because the product works itself together. Right. But the other thing that's happening a lot more recently is virtual compass. And that's something that I've been working with as well. And that creates a whole different dynamic for quality system, because there's a lot more supplier qualifications involved, and it also creates some interesting avenues when it comes to items like investigations and complaint handling I've had some clients where complaint handling seems to be one of the hence to be my bread and butter lately. Particularly since these phase three customer clients, it seems to be the one of Oh yeah, now we need to beef up complaint handling because we're about to really sell they've had it because of clinicals. But right but loosely, right. So one of the key things is what I call reverse logistics. How do you get the product back? And when you were a virtual company, where there is no real artist, where does it go? And it becomes even more interesting when your drug substances being made at company a drug products be made at Company B, packaging and labeling is happy at companies see an all testings happening at Company D. Okay, so where are you sending this?

Dori Gonzalez-Acevedo: 21:02

Right? Great question.

Kimberly Wallbank: 21:05

So I get these interesting logic problems. And I truly enjoy solving logic problems. I think that's,

Dori Gonzalez-Acevedo: 21:15

and there's no one right answer, either, right? And so it's a matter of interpretation and business objectives, and how are you going to handle it and solving that problem? puzzle, right, and then putting in structure to support that on an ongoing basis, right.

Kimberly Wallbank: 21:31

And it goes back to your other point about the organization working together, because quality tends to have to figure that out. But in this particular example, I just provided supply chain needs to be involved. They're the ones who have those relationships with those companies. So they need to have an also somewhat of a quality mindset and work together with quality to help solve those types of issues.

Dori Gonzalez-Acevedo: 21:58

And it's a great the supply chain is just so complicated these days than it was years ago. And and I think globally, we've shown that we were able to handle it, I'll be at COVID vaccine program, right, we were able to handle it in a way that no one thought was, would have never thought possible before. Right. And it was solvable and sustained. Some can argue wasn't fast enough. But frankly, the things that the industry did in such a short period of time in order to get the drug product where it needed to go was pretty remarkable. Be interested to see future, you know, kind of look back and an analysis of that from a timing perspective. But I really wish we could really double down on some of those lessons that we've learned through that process, the risks that we've taken, that were calculated risks in the ton in that time and space, and how to capitalize on that moving forward, right, like how to do that on a routine basis, rather than making an urgent crisis.

Kimberly Wallbank: 23:10

Yeah, absolutely. And, you know, risk is always something that, you know, these companies have to deal with, I mean, risk became the word back in the late 90s. From the FDA, and managing the risk of documenting the risk. And that's another I actually finished doing a talk a few weeks ago on risk based decisions in complex systems. And the key takeaway I was trying to say was that, again, your organization needs to work together, QA can't just make the decision. Sometimes you need your medical affairs team involved to help make the decision, because you're talking about someone's life. And but you also have to have supply chain involved in manufacturing involved, and documenting those decisions and documenting your rationale of why this risk is okay. If the risk is pretty high, what are you going to do to mitigate it? Yep. Yeah. So

Dori Gonzalez-Acevedo: 24:13

Kevin, given all of that you do today, and where you came from? Would Have there been a things that you would do differently? Or how you know, if you were to talk to your, your younger self, you know, if I did this, this and this, I can do it a little bit differently this

Kimberly Wallbank: 24:31

day. Oh, yes. I think I have that conversation with myself pretty much on a daily basis. The key one is to seek out mentors a little earlier in life. I was a little shy and a little nervous. And I felt just I needed just to do what my the senior people in my team told me to do, which again, helps they have knowledge but to also engage reach them in, why are we doing it this way? What was your path to get to where you are, you know, and ask those types of questions. I wish I had done that a little earlier. The other thing is to not take everything a little as seriously as I did, I came out very much, you know, lab coat ready and just tunnel focused, as opposed to trying to think the broad picture.

Dori Gonzalez-Acevedo: 25:27

I think that was very characteristic of the day in the age in which we were in college and what we were conditioned to do, you know, when I interview younger folk today, coming out, they're all open for open ended questions and the right way, that is not the conditioning of you know, as a chemist and a biochemist, by education, that is not the how I was, was conditioned and undergrad and graduate school.

Kimberly Wallbank: 25:55

Oh, no. In fact, I, the reason why I was terrible at r&d was I was so afraid to fail. I was conditioned, you know, you know, as you probably were, that you needed to get it right the first time. And so, but that's not how experiments work. Right. But it's one of those things where being afraid to fail and learn from it. You know, it was this, oh, you failed, so you can't do it again, that was the message we always got. So I think that's one of the reasons why, like, r&d just did not end up working for me, whereas quality was like, you have to get it right, you have to find ways to make sure you get it right the first time.

Dori Gonzalez-Acevedo: 26:40

Yeah, that's interesting, because so as I was a chemical process, an r&d chemist, and so in some ways, but I was put right into generics, that that's where I started. And in generics, there's no room for, I mean, you can experiment, but there's really no room and margin for error, because everything is is commoditized. Right. So while that is a very different look and feel from an r&d perspective, versus the big blockbuster ones, where you have the years to experiment. Albeit those years cost a lot more money. And we see that how long a new blockbuster takes to go to market and the expense of that. But in the generic market, I think for me, it was conditioned, very, very early on that every experiment manner. So every tweaking really matters, and you learn from every lesson all along the way. And that coupled very nicely with the quality management system that evolved for those for that business process, right, because it was so interconnected, because every penny mattered, every ounce of waste mattered. Because we were we didn't have those margins, right. And I think that that is also interesting in relationship to where the industry is going. Because the no one wants to continue to have this burden of this, these exorbitant costs in that and so we need to be smarter in all areas, right? And where to experiment and where to get it right the first time as quickly as possible. And in order to reduce that cost.

Kimberly Wallbank: 28:16

Yeah, I remember my first I worked in r&d I was working on first in class of a diagnostic tool, we were taking something that was a big standalone piece of equipment in a lab in a hospital and trying to find a way to shrink it down to where you could put in an ambulance. So I was working on the assays. Cool, yeah, it was really cool. It was very exciting. And I remember my first experiment that I had experiments before this go well to where we learned things from it like okay, this is not the right configuration. But I had one experiment, just go sideways on me completely go sideways on me, and I'm presenting it to the team. And I'm the only woman in the room. And actually in my team, you know, they were great. I was the only person under 30 I was the only person without a PhD. And but they treated me like an equal and this was the one time I really realized they were doing it because I just went yeah, I failed. It's all my fault. They're like the instrument died on you. Like that's not your fault that the instrument I said, well I should have doubled triple checked it. They go oh, I didn't realize you had superpowers to make the equipment do what?

Dori Gonzalez-Acevedo: 29:41

Yes, you are superpowers. So that's funny. So let's fast forward to what you're doing today. Tell me about your company. What do you guys are doing? How are you servicing and helping your customers?

Kimberly Wallbank: 29:56

So what I'm doing a lot more of is trying to focus on startups. There's a lot of these biotech med device startups coming out with some really fascinating products that are coming to market. So I'm trying to focus on them in helping them find their quality system. And starting off with the whole process of baby steps, you know, you know, this is the bare minimum you need for today, because you're at phase two, phase three clinicals. Okay, now you're heading to commercial. So this is the next where you need to be, so that you're doing these incremental changes as opposed to a massive quality system overload dump. And then I'm doing some little side projects with Marquette University, my alma mater, and doing some other things with some other organizations. Marquette has always been very close to my heart, I've, you know, I graduated 20 years ago. One of the things I went back and I've been talking to Dean Bostick about quite a bit is the biology department, they now call it biological sciences. And helping those students understand that there's many different avenues in their career they could take. You don't need that tunnel of you're either going to medical school, or you're going to become a professor at and I didn't really think much about it until the pandemic hit. And I was trying to get involved from, you know, 1000 miles away, and I did a talk with their entrepreneurial group. And one of the professors from that department was on instead hear your talk was very interesting. I didn't realize this was a past someone could take with our degree, I get a lot of my students coming to me going, what do I do next? And his answer was, oh, and that kind of broke my heart. It was like, it's been like, almost 25 years, and students are still feeling this way. So I've been doing some mentoring with some of the Marquette students. And then Dr. Bostic, once a year does these seminars with alumni from Arts and Sciences of where your career went, how did you go from getting a degree at Marquette and going into your your industry? And what tools did you take with you from your degree. And during my talk this past fall, I actually had a student get on and said, you know, this has been so helpful. She was I actually was thinking about leaving the department and going some in taking going into English, because I didn't know what to do with it, at least English, it was something else and I did everything I could not to cry on the call. In fact, I even told everybody contact me if you have any other questions. And I reached out to the dean after said, please make sure the student has my information, she's more than willing to contact me anytime. So it's, that's been kind of one of my joys is kind of helping them out. I think

Dori Gonzalez-Acevedo: 33:19

what you're doing is wonderful. And I think that there's many examples of that, that making these connections in, in practical ways to help colleges and even in even in high school, because I mean, you know, I met recently, actually the last connects conference, someone that didn't go to college and is now a QA manager. And, you know, he, he didn't have any experience and just didn't know what each fell into it and and worked his way up. And right from high school, he just knew that he was different and wanted to do something different. And I think that there's, there's a lot of different ways that this industry can provide good jobs for folks is just not well articulated. You have to have a certain pedigree or a degree and all that sort of stuff. And that's not necessarily the case at all.

Kimberly Wallbank: 34:17

In fact, the person who trained me fresh out of college and Abbott had a GED. He had been working at Abbott for over 20 years, he worked his way up from I think warehouse or cleaning glass were all the way to the team I was on and between him and the PhDs were great on the team. But if I had a question, he was the guy went to first. And it wasn't that the PhDs didn't know what they were talking about because they were very brilliant. It was not only could he knew it, he also could explain it and made it easy to understand. So it's it's one of those things In fact, one of the things I've been trying to participate in more are these women in STEM talks, you know, from high school and college, and a lot of times I get the pushback of, well, you're not a scientist, you're not an engineer, I'm like, I have the degree. I am in industry, in an industry where science and engineering is needed, and encouraged. Let's show these children or these young people, what other fields they can go into, besides, you know, stem just isn't, you know, going to the moon or saving the whales. I mean, those things are very exciting and very important. But there's other things you can do in STEM. And I think not having people like myself, or you or other people in quality participate in them is definitely a disadvantage to these young people coming out.

Dori Gonzalez-Acevedo: 35:58

I 100%, applaud you and, and 1,000% agree with you. It's the diversity of thought, at all levels of organizations. Regardless, we're talking right now about life sciences, in particular industry, but it exists everywhere, right. And to get away from that hierarchical kind of way of thinking, and to get actionable, meaningful dialogue, to occur needs to have some diversity of thought,

Kimberly Wallbank: 36:27

yeah, and some of these requirements to work up your way to management needs to be really thought through because I

Dori Gonzalez-Acevedo: 36:36

know you're touching on some really hot topics here,

Kimberly Wallbank: 36:39

like micro micro, for some reason, most companies are requiring the director to be a PhD. Okay, well, so you're telling me that someone who has a bachelor's in micro who's been working yours in the laboratory, who has kept up with their training, who has kept up with the academia, the papers, everything else, isn't as qualified as someone who has a PhD. And because me, I think they may actually be more qualified, electrically if they have more personable skills to actually manage the team. And that's the thing that happens quite a bit is that they focus on the technical skills needed to be the manager and not the managerial leadership skills that need to be the manager.

Dori Gonzalez-Acevedo: 37:31

Yes, which I had a dinner last night with a colleague and PhD postdoc, and academia and, and I asked me, So how often do you actually do science anymore? And he's like, you know, it's, it's in because it is, it's we at the end of the day, all of those other skills you just mentioned, are so much more critical to them, the the thing or the widget that we're making, or the thing that we're testing. And while all that's important, we can pull from from other people that information or to get it done. Right. But if you don't have those other rounded facets, we can't get to the next step.

Kimberly Wallbank: 38:14

Yeah, I had a manager once who great guy, that I had to go beg for feedback. So I go, so how, you know, how am I doing? Like, I haven't heard anything, because usually from other managers, you know, once a week, once a month, you were the one on ones. And sometimes they were great. Sometimes they were like, you know, the big like, oh, it seems like you're just getting picked on with every little thing you did wrong for the week. I never would hear I mean, he talked at meetings, and we would discuss experiments and everything else makes so how am I doing? Because doing what you're doing your experiments. So and I'm like, but in my meeting expectations of what you want me to do they go, you're doing your experiments, right? Yes. Okay. Well, just keep doing that. Okay, I mean, I want you to be that robot. Because I have no heels. It's that's just HR stuff. And it was like, but how can I get better if I don't know what I need to work on? Or how am I doing, you know, and it was just kind of like, oh, you're getting experiments done, so everything's fine.

Dori Gonzalez-Acevedo: 39:30

So tell me so how did you? How did you like transitioning, being a consultant separate, you know, running your own business, all that sort of stuff? How do you like that?

Kimberly Wallbank: 39:40

I do. I really like it. I find it quite liberating. I mean, there's some things that you know, I mean, everything has its pros and cons. I mean, I work at the behest of my clients. So while there are lulls in my schedule, which are great, sometimes they're not exactly when I would like them. To be, but it is great not to have to worry about certain politics and accompany I do have to deal with the politics of my clients. However, I do know that that is temporary, as opposed to being focused on me. And just being able to have that freedom to say, You know what, this is the right client for me to work with, because I know I can help them or you know what, I think you need someone else. You know, so the clients who come to me going, just give me your SOP package, I'm like, that is not me. I do not have a standard set of SOPs that I just write and then just hand them out. Because it's not going to work for everybody. And it's probably not gonna work for most people, because I sat at my own kitchen counter and wrote them, and they didn't take an effective way your organization works.

Dori Gonzalez-Acevedo: 40:55

Yeah. Folks don't like that answer. I'd say the same thing. They don't like that answer. And more often than not, I get a request for a proposal for something and they just want to know, well, what do you always do? And it's it's very, very hard to have that conversation enough to be able to slow them down to say, will it matter? It depends? Yeah. It depends on a couple of different things. And and can we have a conversation about that? And when their procurement process is all about just getting numbers? And it's not necessarily numbers that make meaning if if we're not able to have those additional conversations, right, because it is it's it's right sizing, the whatever it is for the right reasons. Right. It gets back to I think, in the beginning, when you said, knowing your why, right. And this is a theme that I think comes up often on these podcasts that I've been talking about, specifically, with the women leaning validation, folks that I've been interviewing is, we are much more interested in understanding the why. I don't know is that gender specific? Not sure. But it's very rare. It comes up in almost every conversation I have with with the women that I've been interviewing for women leading validation is what why are we doing this? Or what is important? Or how, you know, the disguised How come? Is a similar question is still a why question.

Kimberly Wallbank: 42:31

I think the reason it, I mean, I've heard men ask it, but I think women ask it more. And I think it has to do with the fact we are always so overburden with action items. So we've been in least in the last 10 to 20 years have been focused on okay, why do I have to do this? You know, why? Why this. So because obviously most of us are trying to get things off our plate. Because, you know, you know, some people have husbands and children and dealing with household and caregiving of older parents. So we bring some of that thought process to work of why do I need to do this, because this is just one more thing to do. So when you understand the why you're more apt to do it. But also it might be Well, that might not be the right approach. There's a better, more effective, more efficient way to address that particular need. And I think also, it's not just women, I think it's this younger generation coming up behind us who were asking a lot of the whys of why why are we doing this? You know, back to the whole open question thing. You know, why? Why are we doing this? Like, because this seems old and antiquated. Why? Why are we doing this? You so I think they're also kind of pushing us to ask those questions.

Dori Gonzalez-Acevedo: 43:54

Yeah, I do. I feel that a lot. And energizes me I feel validated. Like, thank God, someone else is asking this question. Is that me anymore? Yeah. So what's next for you? Um,

Kimberly Wallbank: 44:08

well, I am starting to do some writing. I have some work related and non work related. Going to working on two articles right now. Round complaint handling. I've been I'm trying to get out of the pigeon hole of complaint handling. However, I it's not going away anytime soon. To get out of that. Yeah. Well, it's, you know, other clients will look at me, you know, or talk to me like, well, you've or other consulting firms who need to bring on additional consultants, and they're like, Well, we're working with this company have that tracker, so I can do Batch Records. They go Yeah, but I've seen like the last five clients you had were a complaint handling and go Well, if you look at what the FDA has been picking on lately, it's been complaint handling. So if they were picking on Batch Records, I would have been doing Batch Records. So But one of the things I've learned from my clients because I feel not only do they learn from you you learn from them, is the key piece of complaint handling that is causing the most headache is the intake triage piece, the piece that happens before the investigation? How do you get the information from the patient and the user? How do you get the product back? So because obviously, like anything else, design control, research, it's garbage in, garbage out. So if you're not doing the first piece, right, you can do the best investigation you want. But you didn't solve your problem. Right? So I've been focusing on some doing some writing on those key pieces. And then I am actually tackling some short stories. I'm cool. There's been, I've been thinking about this since the shutdown. And I've have some ideas in my head, I have these little pieces here or there. So we're going to see where it goes. Because one of the things I've learned from the shutdown the pandemic, and from this generation coming up from behind is why just do one thing, you know, there's other things to try and do something else. And it's weird to do writing because English, I did well in English, but not as well in this as it did in science and math to where teachers tend to, like just just pass English, just, you know, and I wouldn't there with you. So the fact that I'm wanting to write is great. I think science has helped me do that, because I'm like the technical writing piece. So it's this creative pieces kind of give me a different outlet to kind of figure some things out as well. And then continuing some of this work and trying to push the fact that quality is part of STEM.

Dori Gonzalez-Acevedo: 46:57

Yeah. I like that I have some connections, maybe I am we need to hook you up with around that that initiative. I think there's I think it's important topic, as well as in education. And so make sure we'll connect about that outside of here. Because I think that's really important.

Kimberly Wallbank: 47:16

Yeah, I would love that because I keep going I look, you know, and that's the whole, you know, me trying to market myself market. My company is I'm trying to say, I can help you please let you know, please talk to me, I can This is why you should come talk to me, I have some knowledge. And I have it's been difficult for me because I went to Catholic school, you know, you know, younger years, and you didn't do the Look at me, it was you sat in the corner, you did your hard work, if you did it well enough. And all by yourself, you got credit. That's not how the world works.

Dori Gonzalez-Acevedo: 47:54

Yeah. So that is true. And, you know, as a chief member, and a lot of the learnings here last year, with my journey in chief is is really to start taking that, that on individually Right? Like it's is actively saying what I'm good at, you know, publicly right, like that's hard for a variety of reasons, right for us to actually showcase what we do well as women and for whatever variety of reasons comes naturally to many men, it does not necessarily come naturally to women, and how we have to really Buck our own insecurities in order to have that more regularly happen. And so I'm here to support you in that in your journey. It's it's hard to do and and just keep doing it as you just continue to evolve. Right. One

Kimberly Wallbank: 48:53

of the books I love to read, I'm I'm going to blank on the author's I apologize, but the Confidence Code. It was written several years ago, and one of the things that came out was math problems. And how if you they asked, you know, men and women, you know, you're gonna do some math problems, and they did math problems. And they before they graded them, they said, How well did you do? And the women went, did okay, you know, but the men like, Oh, I did great. But they got the same score. You know, so it was interesting of how like, the men were like, Yes, I'm confident I got it. Right. And sometimes they did, and sometimes they didn't, but the women like, I'm not sure because we're, we're looking for that validation. We want someone else to tell us we did it right. And that's one of the things I've learned as a consultant of No, I know what I'm doing. And I need to say that more often I need to share that and but find that communication way to where it's coming off as I'm confident in an expert as opposed to coming from an arrogance. You know, so that's where because to me there's it's very binary. It's either you don't tell people or you're arrogant. So I'm trying to find that happy medium and what that looks like.

Dori Gonzalez-Acevedo: 50:16

Yeah, awesome. Well, we will be sure to link all your contact information in the show notes when this gets published to make sure people know how to find you connect with you on LinkedIn. And reach out so that you can help them in their journeys and where they're at with their on their organization and how you can help them. That sounds good. That's wonderful. Dorie,

Kimberly Wallbank: 50:38

thank you so much.

Dori Gonzalez-Acevedo: 50:40

You're welcome. Kimberly, it has been a pleasure to chat with you and hopefully soon and connects Congress we actually get to meet in person that will be awesome.

Kimberly Wallbank: 50:48

Yes, thank you. I look forward to that too.

Dori Gonzalez-Acevedo: 50:51

Okay, take care.

Kimberly Wallbank: 50:52

Thanks, story. You too.