Director of CMC Quality Assurance
Virtual Vocations Inc, New York, NY, United States
A company is looking for a Director, CMC Quality Assurance.
Key Responsibilities
Build and enhance the CMC quality management system, ensuring scalability through commercial launch Oversee quality assurance for CDMOs and contract testing laboratories, including audits and quality agreements Lead PAI readiness activities and serve as QA lead during FDA inspections and regulatory interactions
Required Qualifications
BS, MS, or PhD in Pharmaceutical Sciences, Chemistry, Biology, or related life sciences; advanced degree preferred 15+ years of experience in pharmaceutical or biotechnology quality assurance, with significant experience in senior CMC QA roles Experience building CMC quality systems from the ground up Deep knowledge of FDA GMP regulations, ICH guidelines, and quality risk management principles Experience with small molecule OSD and managing CDMOs from a QA perspective
Build and enhance the CMC quality management system, ensuring scalability through commercial launch Oversee quality assurance for CDMOs and contract testing laboratories, including audits and quality agreements Lead PAI readiness activities and serve as QA lead during FDA inspections and regulatory interactions
Required Qualifications
BS, MS, or PhD in Pharmaceutical Sciences, Chemistry, Biology, or related life sciences; advanced degree preferred 15+ years of experience in pharmaceutical or biotechnology quality assurance, with significant experience in senior CMC QA roles Experience building CMC quality systems from the ground up Deep knowledge of FDA GMP regulations, ICH guidelines, and quality risk management principles Experience with small molecule OSD and managing CDMOs from a QA perspective