Penelope Przekop, CEO of PDC Pharma Strategy, is a Quality Systems Engineer, and a Compliance Consultant with 30 plus years of experience in the pharmaceutical industry. Her areas of expertise specifically include strategy development, quality systems & assurance, inspection readiness, and organizational training. A down-to-earth person by nature, Penelope is a dynamic leader who fortifies every business relation with her result-oriented mindset. Along with her vast experience, she brings a versatile uniqueness in her work style which appeals to all her clients and everyone who is associated with her. She is sought out for her broad and deep industry knowledge, regulatory expertise, and creative strategic approaches. She frequently speaks, mentors, and delivers training on industry quality management and regulatory compliance topics. Besides being a steadfast pharma industry leader, Penelope is also an accomplished artist and writer. She is the author of ‘Six Sigma for Business Excellence (McGraw-Hill)’ and ‘5-Star Career: Design and Build Yours Using the Science of Quality Management (Productivity Press)’. Her forthcoming book, 5-Star Career: Design and Build Yours Using the Science of Quality Management (9 November 2021), is an amalgamation of how the science of quality management can be applied to both career and life in a more personal way, how the science had a powerful impact on her personal life as her expertise and career evolved, and how the science has far reaching applications that are yet to be explored.

In an interview with PerceptivX, Penelope shares exclusive insight on her background and why it’s high time to revolutionize regulatory compliance strategy in the pharmaceutical industry. She also spoke about the importance of leading authentically, overcoming fears to achieve goals, and things she’d like most to change about the world.

PerceptivX (P): Please give us a brief overview of what PDC Pharma Strategy is about, your areas of interest, and your vision for the industry?

Penelope (P): “Founded in 2019 Jamison, Pennsylvania-based PDC Pharma Strategy is a boutique consulting firm. We develop and execute risk-based strategies that support comprehensive global regulatory compliance throughout the drug development process and product lifecycle. I’m particularly interested in working with clients at the strategic level as early in the drug development as possible to truly start at the start, create regulatory compliance strategies that can smoothly scale and pivot with the trajectory, twists, and/or turns that come, as we all know they will. My vision is to continue to bring the science of quality management to the forefront of the pharmaceutical industry; I believe the value it brings has been overlooked. My mission is to develop, execute, and share new approaches and models for building and managing quality and compliance that is fit for purpose and better suited for our current industry models.”

(P): It’s a great way to move forward! What motivated you to do this? Can you walk us through your journey?

(P): “It’s a long one. During my 30-years in the industry, I have held leadership positions at Novartis, Covance, Wyeth, and Johnson & Johnson, and have worked with numerous Fortune 500 pharma companies. My industry start was in pre-clinical research. I have a BS degree in biological sciences. While working in the lab, I had the opportunity to do a cross-training week in quality assurance. That paved the way for me to transition to that department a year or so later. I worked my way up through various research and development areas, all with a focus on quality assurance and management. After learning about quality management in the late 1990s, I earned an MS degree in quality systems engineering. That’s when my career took on a more distinct focus. As my career progressed, I became more aware of and interested in how industry changes driven by the ten to fifteen-year wave of major technological advances (that began during the mid to late 1990s) left the industry in need of new strategies. Most of the key areas of pharma recognized the need for new strategies, including finance, corporate structure, human resources, supply chain, technology, and operational processes. However, regulatory compliance is a critical area that has been overlooked in terms of strategic change. For the most part, the quality and compliance approaches of the 1980s and 90s have remained constant despite the rest of the industry morphing into the 2021 pharma landscape. Over time, this gap became so clear that I couldn’t stop thinking about it, how and why it developed, and how it could be filled to better align with the current industry landscape. PDC Pharma Strategy was born when I realized that after all my years of technical and creative work, I had developed the unique skill set required to help companies develop regulatory compliance strategies throughout the development lifecycle.”

(P): How do you find new customers?

(P): “I have worked to position PDC Pharma Strategy within the industry through messaging on our website and when I interact with clients and potential clients. I do a lot of industry writing, which is something I enjoy. I also have continued to be actively involved in speaking at industry conferences, teaching webinars, etc. Most of my new work comes from either word of mouth or as a result of my industry writing and speaking.”

(P): What’s your take on the gender gap? Did it affect your career trajectory? 

(P): “I have never focused on gender gaps. I’ve focused on people. I’ve focused on delivering high-quality work and contributing in creative ways. I raised two children, never stopped working, and never felt that being a woman should hold me back. Who knows if it did? I’ve accomplished a tremendous amount. Looking back, I don’t think I realized how powerful my mindset was in essentially pushing worries about gender aside and simply making the career moves that made sense to me. My mother had a career as a successful interior designer when I was growing up during the 1970s and 1980s. She owned a design firm, which was quite unique at the time. She and other women in her generation paved the way. I never doubted that I would have a career and be a mother, and that’s exactly what I did.”

(P): What according to you makes you stand out as a leader?

(P): “I’m dedicated to being authentic in my leadership. I struggled with that for years and wrote about it in my upcoming book, 5-Star Career: Define and Build Yours Using the Science of Quality Management.Throughout my career, I’ve consistently respected the unique value that my staff and colleagues bring. I seek to understand people and to see the best in them. If people enjoy the work that they do, they will naturally want to do their best.” 

(P): On your route to success, what were the biggest fears you faced and how did you conquer them?

(P): “I started out with a tremendous number of fears. Now I have very few. I recognized and worked to face my fears. Some I faced early in my career. For example, I forced myself to become comfortable with public speaking. Other fears took years to overcome. Essentially what drove me was a never-ending desire to move forward in my life. I still feel compelled to move forward.”

(P): Last, but not least, what three things would you like to change in the world?

(P): “I’d wish for an increase in logical thinking across the globe and wish for the world to realize that logic and creativity, religion and science, and work and family do not have to be at cross purposes. I’d wish that every child could grow up feeling truly loved.”