Senior Manager, Quality Assurance
Core
Lead Quality Assurance for Drug Substance intermediates and custom raw material activities, ensuring CMO operations meet global regulatory standards and Vaxcyte quality requirements.
Role type
Senior Manager, Quality Assurance (Biologics Manufacturing)
Builds
Drug Substance intermediates and custom raw materials for clinical-stage vaccine innovation
Domain
Biopharmaceuticals / Vaccine Development / Contract Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP knowledge, FDA/EMA regulations, ICH guidelines, biologics manufacturing processes, Quality Systems, technical writing, cGMP standards, risk assessment, change controls, CAPA management, deviation investigations, batch record review, disposition package review, technology transfer documentation
Preferred skills
Clinical and commercial product knowledge, supplier manufacturing investigation guidance, process improvement project leadership
Technologies
None stated
Responsibilities
Serve as QA representative for Drug Substance intermediates and custom raw material; Review and approve internal and external documentation for compliance; Conduct thorough QA review of CMO executed batch records; Review disposition packages for release; Develop and maintain QA procedures and policies; Drive resolution of quality performance issues with contract manufacturers; Support technology transfer activities; Participate in process improvement projects
Seniority
Senior, hands-on IC with management oversight