Sr. Project Manager, Quality Assurance (QA)

Job Responsibilities

• Maintain and revise QA related procedures, as needed.
• Maintain cGMP training systems and perform on‑site team member training in Quality related matters.
• Ensure GxP support and oversight, as applicable, for relevant site functions and activities.
• Support QA team members with senior QA level knowledge, experience, guidance, coaching and mentoring, as required.
• Perform QA batch record review and disposition of manufactured early‑phase clinical product batches.
• Provide final QA approval of investigations and disposition of any impacted product batches.
• Evaluate deviations and propose batch rejections, if applicable.
• Perform QA review and approval of the following, as needed:
  • Environmental monitoring data in GMP cleanrooms and adjacent areas, as well as Clean Utility monitoring data.
  • Investigation of non‑conforming product.
  • Investigation of out‑of‑s...