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Penelope Przekop, MSQA, RQAP-GCP
Founder & CEO
Penelope Przekop, MSQA, RQAP-GCP, is a Quality Systems Engineer and GxP Quality Assurance/ Systems and Compliance Consultant with more than 30 years of industry experience. She has consulted with numerous top 100 pharma and biotech companies and is often sought out for her broad and deep quality systems experience both from an operational and quality assurance perspective.
She has held leadership roles at Covance, Novartis, Wyeth, and Johnson & Johnson as well as interim VP-level quality and compliance roles as a consultant. She has fulfilled the role of Chief Compliance Officer. Penelope earned a BS degree in Biology from Louisiana State University and an MS degree in Quality Systems Engineering from Kennesaw State University.
Penelope is a graduate of the Rutgers University Senior Leadership Program for Professional Women and the Smith College Customized Program for Women’s Leadership. She’s the author of Six Sigma for Business Excellence (McGraw-Hill) and frequently writes, speaks, mentors, and delivers training on industry quality and compliance topics. Her book, 5-Star Career: Define and Build Yours Using the Science of Quality Management, launched November 2021 from Productivity Press.
Our Team
Valerie Przekop, MS, Quality & Compliance Consultant
Valerie Przekop, MS, provides ad hoc quality and compliance consulting to PDC clients. Valerie earned an MS in Biomedical Informatics, a BS in Management Science & Engineering, and a BA in Psychology from Stanford University, where she was a track & field varsity student-athlete. She has co-authored articles for Clinical Leader and Life Science Leader Magazine.
Mimi Kim, Quality Assurance Specialist
Mimi Kim joined PDC in November 2021 as a Quality Assurance Specialist. She provides QA support to PDC clients in the areas of inspection readiness, document management, and planning and execution of electronic quality management systems. She is a registered pharmacist with 22 years of experience. She earned her degree at the Massachusetts College of Pharmacy and Health Sciences. She also has experience providing social services support as a certified social services designee.
Joon Sung Park, Quality Assurance Specialist
Joon Sung Park joined PDC in November 2021 as a Quality Assurance Specialist. He provides QA support to PDC clients in the areas of inspection readiness, document management, and planning and execution of electronic quality management systems. Joon earned a B.S. degree in Neuroscience from Boston College. He has several years of experience in the healthcare industry related to ensuring quality documentation and has technical experience in ophthalmic patient care.
Ananya Bharath, Quality Assurance Intern
Ananya Bharath is a B.S. candidate in the University of California, San Diego Class of 2023, studying Chemical Engineering, with a specialization in Biotechnology. She has gained management and leadership experience as current Vice President of the UCSD Chem-E-Car project team, and research experience at the UCSD Jin Zhang lab where she studies cellular signaling pathways. As a PDC intern, she is gaining an understanding of the drug development process and the associated regulatory requirements. She contributes to PDC internal initiatives and provides additional support, as assigned.
Anisha Chaudhary, MS, Quality Assurance SQA Mentoree
Anisha Chaudhary joined the PDC team thru the Society of Quality Assurance (SQA) mentoring program. She is working with Penelope Przekop to strengthen her GCP and PV quality assurance knowledge and skills. Anisha has ~7 years of industry experience with companies including TaTa Consultancy Services, Takeda, and Shire. She has a B.S. in pharmacy and earned her M.S. in Project Management (concentration in Clinical Research) from Northeastern University in Boston, MA.
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