Director of Product Quality

A company is looking for a Director, Product Quality Leader. Key Responsibilities Serve as the primary contact for product quality topics within the CMC team, influencing global strategies and implementation plans Develop and prioritize long-term product quality strategies and lead the cross-functional Quality Partner Team to manage deliverables Oversee product quality risk management, regulatory submissions, and initiatives to improve operational efficiency Required Qualifications BA/BS in life sciences or related field; advanced degree preferred 12+ years of experience in Biotechnology, Pharmaceutical, or Medical Device industries, preferably in gene therapy or biologics Demonstrated leadership capability in a cross-functional environment In-depth understanding of cGMP principles and regulatory standards Broad knowledge of Quality in biologic and chemical processes, drug development, and analytical methods

Apr 9, 2025 - 16:55

A company is looking for a Director, Product Quality Leader. Key Responsibilities Serve as the primary contact for product quality topics within the CMC team, influencing global strategies and implementation plans Develop and prioritize long-term product quality strategies and lead the cross-functional Quality Partner Team to manage deliverables Oversee product quality risk management, regulatory submissions, and initiatives to improve operational efficiency Required Qualifications BA/BS in life sciences or related field; advanced degree preferred 12+ years of experience in Biotechnology, Pharmaceutical, or Medical Device industries, preferably in gene therapy or biologics Demonstrated leadership capability in a cross-functional environment In-depth understanding of cGMP principles and regulatory standards Broad knowledge of Quality in biologic and chemical processes, drug development, and analytical methods