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Associate Director - Quality Assurance (QA - CMC)
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- Company is seeking a highly experienced, motivated, and innovative quality leader with strong experience in early and late-stage development to join our Quality team as Associate Director, Quality Assurance to support drug development from Phase 1 to late-stage development.
- This individual will partner with CMC, Clinical, Regulatory Affairs, and other corporate stakeholders to ensure Company’s clinical and commercial products follow cGMP framework and guidelines.
- The Associate Director, Quality Assurance will be based in our Northern New Jersey, offices 1 - 2 days a week (flexible schedule for the ideal candidate).
- Provide quality leadership, strategy, and compliance oversight to CDMOs, CMO, CRO, CPO, Third Party Vendors.
- Responsible for Management and maintenance of the Veeva Quality Docs System, including document drafting/Authoring, reviewing, approving, and finalizing internal quality documents (SOPs, Wis, Policies, Forms, etc.)
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