Sr. Director, Quality Assurance for Quality Control
$229,000–$268,000 year
RemoteUnited States
Job Summary
Lead quality oversight for method validation, release, and in-process testing of Drug Substance and Polysaccharides. Serve as primary liaison for internal QA and external collaborators to support analytical program needs. Review and approve GMP documentation including specifications, validation reports, deviations, and CAPAs. Partner with QC and vendors to set performance indicators and drive resolution of quality issues. Lead investigations of testing deviations and OOS results. Contribute to regulatory filings and ensure documentation readiness for health authority inquiries. Champion a culture of quality excellence by identifying systemic gaps and establishing performance standards across internal teams and external partners. Manage geographically distributed QA teams while navigating distinct regulatory environments in Switzerland and San Carlos.
Required Qualifications
- Bachelor's degree in Biochemistry, Chemistry, or a related field
- 15+ years of relevant industry experience
- Thorough knowledge of applicable FDA, EU, and ICH regulatory guidelines and pharmacopeia for method qualification and validation in biologics and vaccines
- Proven expertise in applying these regulations to develop practical solutions and phase-appropriate analytical strategies
- Experience working with biochemistry, immunoassay, or microbiological assay techniques in a Quality Control environment
- Excellent organizational and project management skills, with the ability to handle multiple projects under tight timelines
- Excellent written and verbal communication skills, including the ability to work effectively in cross-functional teams
- Previous experience in validation and transfer of analytical assays
- Demonstrated ability to build and develop high-performing QA teams and influencing cross-functional and executive stakeholders in a fast-paced commercial-stage biotech company
- Knowledge and experience in Risk Management principles
- Ability to integrate and interpret interdisciplinary project information; with at least a high-level understanding of the drug/vaccine development process
- Ability to work globally with CMOs in different countries and continents
- Experience managing geographically distributed QA teams across multiple sites or countries, with the ability to build cohesive quality culture and consistent GMP standards across locations
Desired Qualifications
- Knowledge in both clinical and commercial product
- Experience in BLA submission and commercial launch
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