Vice President of Quality

San Diego

*BioPhase Solutions specializes in recruiting top talented professionals for the San Diego County Scientific community. We are currently looking for an ONSITE* ***VP of Quality Assurance*** *to work for a leading San Diego clinical-stage biotech company.* **Responsibilities** * Lead Quality Assurance and Compliance activities across U.S. and global operations within a regulated biotech or pharmaceutical environment. * Oversee GxP and data integrity activities across clinical and nonclinical programs, investigator sites, manufacturing partners, and external vendors. * Develop, implement, and maintain a robust Quality Management System supporting clinical development, manufacturing, and commercialization readiness. * Design and execute risk-based quality strategies to identify, assess, and mitigate compliance risks. * Provide quality oversight of vendors and partners, including qualification, audits, inspection readiness, and ongoing compliance monitoring. * Direct investigations into quality events and deviations, including oversight of root cause analysis and CAPA implementation. * Oversee review and approval of batch records, release testing documentation, and critical quality records. * Lead preparation for regulatory inspections, including pre-approval and routine inspections by global health authorities. **Requirements** * Bachelor's degree in Life Sciences or equivalent experience. * 15+ years of progressive Quality Assurance experience within biotech or pharmaceutical development, including senior leadership responsibility. * Demonstrated experience supporting clinical development programs from early phase through Phase 3. * Strong working knowledge of FDA, ICH, GCP, CFR, and global regulatory requirements. * Proven experience establishing and maintaining SOPs, quality systems, and QA/QC processes. * Experience leading site and vendor audits and managing inspection readiness activities. * Ability to manage multiple priorities in a fast-paced, regulated environment. **\*Willingness to travel approximately 10--15%.** **What we offer:** As we work to develop innovations that take care of others, we also work to care for our teammates' professional and personal growth and well-being. · Full support and career-development resources to help you reach your potential · A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act *Apply now and let's make work better!* www.biophaseinc.com