Sr. Director, Quality Assurance for Quality Control
Core
Ensuring compliance with global regulatory guidelines and overseeing QA activities for Vaxcyte's PCV Polysaccharides and Drug Substances pipeline.
Role type
Senior Director, Quality Assurance (Biologics/Vaccines)
Builds
High-fidelity vaccines to protect against bacterial diseases
Domain
Biotechnology / Vaccine Development / GMP Compliance
Deliverable
client delivery
Required skills
GMP compliance, method validation, regulatory guidelines (FDA/EU/ICH), risk management, vendor management, quality investigations, cross-functional leadership
Preferred skills
BLA submission experience, commercial launch experience, clinical product knowledge
Technologies
Biochemistry, immunoassay, microbiological assay techniques
Responsibilities
Lead quality oversight for method validation and release testing; Review and approve GMP documentation and validation reports; Drive resolution of quality issues with contract manufacturers; Lead quality investigations of deviations and OOS; Contribute to regulatory filings and audit preparations; Develop and update GMP policies.
Seniority
Senior, hands-on IC with team management
