Director GMP Quality Assurance Small Molecule

  • 200000 USD - 200000 USD
  • South San Francisco, United States
  • Permanent

We are working with an exciting biotech working with autoimmune diseases that is looking to bring on a Director of GMP QA to oversee small molecule solid oral dosage programs across a network of CMOs for DS and DP of multiple late stage and early programs. This role joins a veteran leadership group with commercialization experience.


  • 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.


  • 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.
Martin Wenzel Division Director

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