Manager, Drug Product, Packaging
Listed on 2026-10-18
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Quality Assurance - QA/QC
Regulatory Compliance Specialist, Quality Engineering
Role:
Lead packaging technical operations for commercial-stage oncology products, overseeing transfer, qualification, validation, lifecycle management, and continuous improvement at external CMOs.
manage packaging performance, assess and ensure site capability, lead technical transfers, qualification, validation, and post-approval changes; address deviations and quality issues; collaborate with Quality, Supply Chain, Regulatory, and Manufacturing teams to ensure cGMP compliance and inspection readiness.
Requirements- Bachelor's or Master's in Packaging Engineering, Packaging Science, or related field
- 6-8 years of experience in pharmaceutical, biotech, or regulated industries
- demonstrated expertise with packaging systems, equipment, validation, and quality systems
- experience managing external CMOs and supporting regulatory audits
strong project management, cross-functional collaboration, technical writing, and travel readiness.
High-Valuefocus on commercial biologics or small molecules in oncology, lifecycle management, validation and qualification expertise, cGMP compliance, and external partner oversight.
Work setuponsite at Redwood City, CA, with travel as needed.
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