Tami Frederick

PAI Pharma
Vice President, Quality
Tami is a Vice President of Quality. She the Chair of ISPE's Advancing Pharmaceutical Quality team. Tami is a co-author of the 2022 ISPE APQ Series, Quality Management Maturity Program five guide series. Tami led the PDA/ISPE Culture Collaboration team authoring the Root Cause Analysis Guide in 2019 and co-authored ISPE Cultural Excellence report in 2017. She is a member of the ISPE Regulatory Steering Team.

Tami is Global Quality Leader with 30 years of experience in the Pharmaceutical Industry. She is a chemical engineer by trade and cultural excellence consultant. Tami has held positions in Corporate Quality, QA & QC Operations, Data Analytics and QMR, Regulatory Affairs, R&D, Operational Excellence, and Technical Engineering. She is a certified Lean Six-Sigma Blackbelt and a Certified Quality Engineer. She is also HACCP certified and a Safe Quality Food Practitioner. Her experience spans solid, semi-solid, and liquid drug dosage forms; API’s, Medical Device, and Infant Formula/Foods. Tami has led multicultural Quality teams in the implementation of global quality systems such as global change control, EDMS, SQM, quality investigation and CAPA, QMR & data analytics, global technology councils, and quality compliance audit and inspection. She is a strategic, global continuous improvement leader and change agent advancing the culture of quality throughout all levels in the organization.

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iSpeak Blog
Elevating Pharmaceutical Quality: Insights from the FDA’s Office of Quality Surveillance and ISPE’s APQ Program

Every dose of medicine represents a promise of quality—a commitment to safety, efficacy, and availability for the patients who depend on it. At the 2024 ISPE Annual Meeting & Expo, Jennifer Maguire, PhD, Director of the US Food and Drug Administration’s (US FDA) Office of Quality Surveillance (OQS), outlined how the agency is transforming its approach to pharmaceutical quality surveillance...