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Senior Manager, Compliance & Quality Systems
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$210,000 a year
Full-time
- This individual will be responsible for implementing and managing the site Quality Systems, Supplier Quality, Training and Document Control programs.
- Direct the compliance programs for all cGMP areas and promote a strong Quality culture within the global organization including a strong presence in Quality, Manufacturing, MSAT, Supply Chain and Purchasing, Analytical Development, Process Development, and Engineering
- Support tech transfer of late stage/commercial cell therapy products and equipment coming through the organization pipeline
- 10+ years of experience in a GMP environment in pharmaceutical, biologics, vaccines, cell or gene therapy operations, including solid experience in Quality Systems and Regulatory CMC
- Excellent knowledge of the regulations for biologics, cell and gene therapy products
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