Sr. Director, Quality Assurance for Quality Control

Thorough knowledge of applicable FDA, EU, and ICH regulatory guidelines and pharmacopeia for method qualification and validation in biologics and vaccines, along with 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.

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 in both clinical and commercial product desired.

Ability to work globally with CMOs in different countries and continents.

The compensation package will be competitive and includes comprehensive benefits and an equity component.

$229,000 – $268,000 (North Carolina)

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

Lead quality oversight activities related to method validation, release and in-process testing for Drug Substance and Polysaccharide

Serve as the primary liaison within Vaxcyte QA and with outside collaborators, building partnerships that support analytical needs for relevant programs.

Lead review and approval of internal and external GMP documentation for compliance, including specifications, Certificates of Analysis, validation reports, deviations, change controls, risk assessments, and CAPAs as they relate to polysaccharides and drug substance; apply technical and compliance expertise to critically evaluate reference standards, test methods, protocols, and raw data packages from CMOs and contract testing laboratories.

Partner with QC, vendor management, and contract labs to set key performance indicators for monitoring vendor effectiveness.

Drive resolution of quality performance issues with contract manufacturers and testing organizations

Review Quality Agreements and regulatory documentation as required.