Director GMP Quality Assurance Small Molecule

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.

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.