A booming pharmaceutical company is looking to expand their team with a Key hire of a GMP Sr. Manager of Quality Assurance with experience in a Pharma Manufacturing setting! As a Sr. Manager of GMP, one would be providing quality oversight of CMO's all while representing the Quality Assurance department on project teams, special assignments etc.
- The successful candidate will quality expertise and leadership.
- Working closely with the CMC group to support all external manufacturing and related activities, while ensuring regulatory compliance and minimizing risk.
- Work with CMOs and CMC group to release drug substance, drug product, placebo, intermediate and finished product lots) for clinical and/or commercial use
- Provide quality oversight of registration activities in support of NDA submissions by assuring inspection readiness for manufacturing operations.
- Ensuring robust internal processes and systems are in place to support Infinity's CMC development programs.
- Review/approve batch records, protocols, reports, analytical results, and documents associated with investigations, OOS results, deviations, and corrective/preventive actions, etc
- Conduct internal audits, track progress, and trend results, as needed.
- 5+ years of extensive hands-on experience in a biotech or pharmaceutical drug development company with strong working knowledge of cGMP quality systems.
- Experience in CMC operations and/or analytical development is strongly preferred.