Penelope Przekop is a biopharmaceutical quality assurance and corporate compliance executive consultant with global R&D and commercial expertise.‍Ms. Przekop began her career serving in preclinical research, regulatory affairs, and quality assurance positions of increasing responsibility at Hoechst-Rousell. She went on to hold leadership roles at Covance, Wyeth (acquired by Pfizer in 2009), Johnson & Johnson (J&J), and Novartis. She developed and oversaw the first global pharmacovigilance quality and compliance departments established for both Wyeth and J&J.‍During her career, Ms. Przekop established and oversaw numerous global GxP quality management systems, quality assurance processes and groups, audit programs, and regulatory inspection readiness programs. She has conducted numerous GxP mock inspections and facilitated numerous regulatory inspections. She serves as fractional Chief Compliance Officer and Data Protection Officer for industry clients.‍Ms. Przekop received her MS in Quality Systems from Kennesaw State University’s School of Engineering and BS in Biology from Louisiana State University. She is a graduate of the Rutgers University Senior Leadership Program for Professional Women and the Smith College Customized Program for Women’s Leadership. She has authored quality management-related books published by McGraw-Hill and Productivity Press.#compliancestrategy #pharmacompliance #author #pharmacovigilance #regulatoryinspections #FDA #MHRA #EMA #pharmaceutical #qualityassurance #qualitysystems #oversight #GXP #strategy #dataprotection