Madeline McLean, MA, C.C.C.
Madeline D. McLean is a Quality Assurance leader and lifelong learner focused on improving industry standards through values-driven leadership. With over 13 years of experience in FDA-regulated and high-growth settings, Madeline has built a career at the intersection of strict technical compliance and people-centered development.
Currently working as a Quality Assurance Specialist, Madeline is recognized for her ability to handle complex regulatory challenges while promoting a culture of operational excellence. Her work includes designing and executing impactful training programs, such as a company-wide Good Documentation Practices (GDP) initiative and a strong Allergen Program for more than 700 employees. By fostering collaboration across different teams, she has streamlined essential processes and reduced batch record turnaround times by 25%.
Madeline believes that real influence comes from being open and mentoring others. Instead of just explaining "what" quality standards are, she empowers emerging professionals by sharing "why" that knowledge matters. This approach turns compliance into a shared mission and equips her peers and mentees with the critical thinking skills needed for long-term career success.
Madeline continuously updates her skills to fit the needs of a modern supply chain. Her leadership shows that when you prioritize values and invest in the growth of others, you build a lasting legacy of integrity and excellence.
• Certified Christian Counselor
• Scrum Certification
• Process Improvement Certification from ASQ
• Certified Auditor
• PCQI Certified (two certifications)
• Campbell University – Bachelor of Arts (BA), Political Science and Government
• Moriah Institute of Christian Studies – Master’s Degree, Christian Studies
• Destiny Bible College - Certified Christian Counselor
• Fayetteville State University - Teacher Certification - History and Special Education
• Influential Women 2026
• Influential Women
• ASQ (American Society for Quality)
• Phone Counselor, SAFE of Harnett County
What do you attribute your success to?
One of the most significant accomplishments in my career was developing audit training at my previous company. One day, I had an idea; let’s create a video about being audit-ready and what it involves. The company had a fantastic media team, so we created a video that became part of their training materials for staff. It explains what to do during an audit, how to behave, what to say and what to avoid. I consider this one of my key achievements because it has lasted, and it was used company-wide with over 700 employees. I would walk through the building, and people would say, “Audit ready, there’s that audit lady.” I didn’t care if they knew my name—just wanted them to understand and be ready for audits. It encouraged people to take responsibility for their roles in the process. The idea is that it’s crucial for us to run our business in a way that we are always audit-ready; we don’t prepare for an audit, we maintain our audit readiness.
What’s the best career advice you’ve ever received?
Just be yourself! Be confident!
What advice would you give to young women entering your industry?
Always be ready and recognize how important process and compliance are. Take charge of your responsibilities, welcome learning opportunities, and aim for excellence in all your tasks. Being ready for audits isn’t just for inspections; it’s a way of thinking that supports high standards all the time.
What are the biggest challenges or opportunities in your field right now?
Staying audit-ready all the time is tough. Running about 43 internal audits a year keeps everyone busy, and keeping quality at the forefront while monitoring the environment adds another layer. When big problems hit, the workload gets intense fast. On the upside, there’s a chance to build better training, streamline how things get done, and really weave audit readiness into the company culture.
What values are most important to you in your work and personal life?
I think whatever we do, we owe it to ourselves to do it well. Not perfect, but with real effort and integrity. I’ve always been a lifelong learner—there’s just so much to keep up with in my field. I’ve chased after certifications and training whenever I could, which has kept me sharp and growing. My faith’s a big part of who I am, too. I have a master’s in Christian studies and I’m a certified Christian counselor. That work feels close to my heart. Even before the official certification, I was already counseling people formally and informally, just by being involved at church and connecting with folks.
At some point in the future, I will start a counseling business for people who want to reach out, maybe a service like Better Help, but with a Christian approach. It just feels right.
