Vice President of Quality

Overview

Bio Phase 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.

• 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.

• 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.

Travel – Willingness to travel approximately 10–15%.

• 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