Title: Quality Assurance Manager
Location: San Francisco, California
Summary: This booming bio pharmaceutical company is committed to the treatment of cancer by utilizing their therapeutic platform in order to transform lives with safe and effective therapies in the immuno-oncology hemisphere. With rapid growth and a broad pipeline including 5 clinical stage programs, this roaring biopharma organization is looking for an experienced QA individual who will successfully perform quality oversight while managing cGMP activities in addition to their CMO's and CTO's.
- Managing Quality Assurance fundamental requirements for disposition of GMP batches at CMO's
- Providing guidance and structure to both internal and external partners on CB, DS, and DP productions in order to assure compliance with FDA and EU requirements.
- Review and approve documents regarding protocols, Sop's and more.
- Leading the quality control team on method transfer, validation and qualification
- Oversee change control documentation, deviations, OOs Results, and investigations.
- Achieve quality management within GMP productions.
- Perform and Participate in audits both internal and external (CTO's and CMO's)
- Aid in the coordination and preparation of regulatory organization inspections while managing complaint investigations
- Ensure unification with supply chain to ensure clinical supply to clinical studies.
An Ideal Candidate will have:
- 5+ years of experience in Quality Assurance relevant to the roles responsibilities
- 1+ years of experience with oversight and guidance of CMO's
- Clinical stage parental drug manufacturing and development experience
- Insurance, health, and wellness benefits include coverage with vision, dental, and disability
- Pension, 401 K, and retirement plans in place upon employment
- Stock purchase options available
- Vacation and PTO with Holidays off