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Michelle Lott – Being a RA/QA consultant

The benefits & challenges of being a RA/QA consultant

Michelle Lott embodies the grit and determination associated with being a Southerner. Running a startup for her was a matter of when not if. In 2010, she founded leanRAQA which primarily helps startups and small to mid-sized companies with regulatory strategies, audit preparation and remediation, quality systems compliance and technical support services.

LeanRAQA serves the medical device, dietary supplements, biologics, pharmaceutical, cosmetics, and food industries. Her company is based in Arizona and has been virtual for the last 6 years with clients all over the US and the world.

In this episode, we dig into the determination Michelle needed to build a startup while going through major life changes, the lessons she’s learnt running a startup, what she looks for in hirees and her take on work-life balance.

Michelle also talks about the benefits of being self-employed, the importance of brand consistency and she gives advice for people willing to become independent or to start their own business.

How did you get into RA/QA?

Michelle’s career started in the lab where she was an expert witness in forensic toxicology at the Mississippi Crime Laboratory. She also had experience managing a family business after she was a toxicologist.

When she moved to Northern Mississippi, she applied for a chem lab position at Baxter Healthcare but didn’t get it. “I was really surprised because I knew I was the only candidate that had ever actually worked in a lab.”

A few months later, Baxter Healthcare called her for an internal auditor role. They thought she was the perfect fit because of her personality and her technical know-how of working in a retail public space.

“They left a pile of regulations on my desk because that plant made medical devices, pharmaceuticals combination products and ran three types of sterilization. They said, ‘Here’s a stack of regulations you need to know, your first audit’s in a month.’ “

It was after Baxter Healthcare, where she got a job as a Regulatory Director

Working in a New Role with no Experience

It took her a while to become familiar with the regulations and the role. At the beginning, most of it didn’t make sense to her. “I remember I got sent to do an audit for a facility in Puerto Rico and I literally brought 10 pounds worth of books and interpretations with me so that I could reference things at night and cite them in my audit report.” She immersed herself fully, studying all the time and after 3 months, she finally felt like she had a grasp of what she was doing.

Why Auditors find it Easy to Transition to Careers as RA/QA Professionals

According to Career Trend, “Auditors help top leadership manage corporate affairs, providing guidance on various issues ranging from financial accuracy to internal controls to regulatory compliance.”

“Auditors really have to be able to trace something back from a post-market surveillance activity side or a manufacturing issue side and then trace that issue maybe all the way back into the design, the risk management, change control.”

These overlapping skills between a good auditor and regulatory and quality professional make it natural to transition to a career in RA/QA.

Growing in the RA/QA industry

Michelle worked at Baxter Healthcare for 3 years, after which she moved again, this time to Tucson where she got a job working at a mid-sized respiratory anaesthesia therapy company.
Four months in, she was promoted to be the regulatory affairs manager.

The new position was very demanding but she’s grateful for the experience because what she learnt there and during her time in Baxter would have normally taken decades to learn elsewhere.

Skills to Look for when Hiring Regulatory Professionals

    • They should be able to come up with a plan and offer options and each option should include a list of consequences.
    • They should be able to identify their degrees of freedom. A lot of regulatory people tend to be rigid and take a firm stance instead of opening their mind to possibilities.
    • Be able to work with people from different parts of the company such as manufacturing or sales to be able to find a workable solution for the whole organization.
    • Willingness to learn and take feedback especially for junior positions.

What made You Decide to Start Your Company?

Michelle watched her grandfather and father running their own businesses, so for her, running a business was in her blood. But it was the way that regulatory and quality professionals got treated and the names that they were called that propelled her to start her own company. “I’ve been called the business prevention expert, the stopper, the blocker and the police.”

She wanted to work for people who valued her services. For her clients, now she’s a collaborator and not an employee who gets a cheque regardless of how their report and strategy affects the company. She’s more like an outsourced member of their regulatory and quality team and their business strategy.

Lessons from Founding a Company

As a founder, you’re continuously learning and adapting. If you insist on being rigid and only trying to do things one way, it will affect your revenue, your growth, and even your work-life balance.

2 lessons Michelle had to incorporate where:

    • Learning to keep the pace and building the infrastructure to support the growth of her
    • Relearning what she thought she knew about running a business. Growing up, she was critical of how her father ran his business and made mental notes not to do things the way he did. Having started her own company, she realized it wasn’t as black and white as she thought and had to change the way she thinks.

Expectations vs Reality when Starting a Company

“I was using my lunch breaks, nights, weekends, vacation time to build my business on the side so when I pulled the plug on my real job that was paying the bills, I had just enough clients to be at the poverty line for the United States. “

During the period when she left her job, she was also getting a divorce and had just bought a house on her own.

Top tips for starting your business

A lot of employed people fall into the trap of believing that they will move with the clients that they currently have or that they can rely on their network when they start their business. It’s a risky assumption. The truth is:

    • You can’t depend on word of mouth to pay the bills. Inbound sales are not enough.
    • You need to invest in your company. Michelle invests tens of thousands of dollars in overheads like marketing, conferences, lawyers to review contracts, bookkeeping and taxes. “All of these are commitments to having a consistent business.”

How Important has Brand Been to Generate Business?

Again, she doesn’t rely solely on word of mouth to generate business. Branding has played a major role in bringing in revenue. Besides consistently marketing her brand, she has trained her contractors on what her brand looks like and who she is so that they can also be her voice.

Being consistent with her customer service and deliverable has also been key to growing her brand and generating business.

Skills that a Founder Should Develop in Themselves

There are founders that naturally have personalities, skill sets, and eccentricities that set their companies up for success. If you know that you lack those traits, you need to develop them otherwise the growth of your company will be limited.

Also, if you’re aware that you have a stickin-the-mud kind of personality, work on being personable. If your clients enjoy working with you, they will be quick to
cooperate with you as you design strategies and solutions for them.

Self-Improvement and Self Care

    • In her last job, she negotiated for a year’s worth of training with the company’s corporate coach which was transformative for her.
    • She has a tendency to be self-critical especially when she’s pushing the boundaries of her comfort zone and researching so that she can be more confident. She has learnt to give herself a break and not be a bad boss to herself.
    • She’s made her health a priority by managing it and having a good work-life balance.
    • Building the infrastructures and delegating such as getting a bookkeeper and hiring an employee so that she can keep going without burning out.
    • Journaling helps her clear her head and solve problems. She does it futuristically by visualizing how a problem will look like once it’s solved and then working backwards from that.

Work-life Balance

It’s been difficult for Michelle to find work-life balance because of how committed she saw her father and grandfather were to their businesses. She knew that she didn’t want to repeat the cycle and even with her new marriage and family, she didn’t want to repeat the same mistakes
she had made previously.

“Redefine it for yourself as maybe it’s not ‘I turn everything off at 6’ but it’s what if your work and life ebb and flow together and there’s no hard line because a hard line is a job. If you own your own business, it’s something you should enjoy. It doesn’t mean that it’s something that you can’t turn off and unplug.”

The Biggest Challenge She Has Experienced Running leanRAQA

This period during the pandemic has been the biggest challenge she’s ever gone through with her company. Her clients are working from home so now they’re constantly messaging her, emailing her and calling her and she has to reassure them that her employees are very capable.

To add to that, she’s trying to scale her business fast enough to keep up with its growth.

Advice to Those Thinking about Starting their Own Business

Get a personality profile to discover where you need to work on yourself to be able to run a business.

Test the waters of running a business while you’re still employed to find out whether you’re suited for it. You can do this by working with people that have consulting firms.

Running a business on the side while employed will ensure you still have an income to depend on as your business grows. It will also give you time to adjust to running the business without
pressure rather than if you quit and jumped straight into it.

If You Could Have a Superpower, What Would it be?

“All-knowing so that I don’t have to read thousands and thousands and thousands of pages of regulation because that would help with my work-life balance.”

Who Has Been your Inspiration?

““My Dad in a lot of ways. Always seeing that business was always an option for me. And now to see how much my business has grown and he’s so proud and he’s moved out of that role of telling me what to do. To have your dad like a fan is so cool.” Her husband has also helped her accept who she is and see her supposed flaws as strengths.

The Next Step

In the short term, Michelle intends to set up an auditor training program. She’s also considering writing a book.

What’s your legacy?

People: Patients that are healthier than they would have been without the device that I helped bring to the market. The entrepreneurial customers that I help to make successful and make their own legacies on the world. The subcontractors and now employees that I’ve set free to pursue their version of work-life balance and what they want out of life.
It’s that whole spectrum of people from the patient to those working under me.

It’s never been about the money. It’s been about the legacy.

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