Director GMP Quality Assurance Small Molecule

2 weeks ago

South San Francisco, United States People With Chemistry Full time

. We are working with an exciting biotech workng with autoimmune diseases that is looking to bring on a Director of GMP QA to oversee CMOs, support the Sr. Director of QA, and experience in small molecule solid oral dosage.

Responsibilities: Provide quality operational support for CMC teams and assist in building quality systems and processes. Oversee all quality-related matters concerning manufacturing, testing, and release at a Contract Manufacturing Organization Lead and support external quality activities such as batch reviews, tech transfers, deviations, and supplier qualifications. Author, review, or approve quality documents including agreements, certificates of release, and audit reports. Represent Quality on project teams, Health Authority Inspections, and QA to QA meetings.

Qualifications: Five or more years of people management experience. Strong understanding of small molecule manufacturing, preferably with experience in solid oral dosage. Experience with a small virtual company and Quality Control is a plus. Extensive GxP knowledge from early phase drug development through commercialization.

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