BioPhase · 1 week ago
Vice President of Quality
SD Metro Area
Full-time
Onsite
Director/Executive
$280K/yr - $400K/yr
15+ years expBioPhase Solutions specializes in recruiting top talented professionals for the San Diego County Scientific community, and they are currently looking for a Vice President of Quality Assurance to work for a leading San Diego clinical-stage biotech company. The role involves leading Quality Assurance and Compliance activities across U.S. and global operations within a regulated biotech or pharmaceutical environment.
BiotechnologyPharmaceuticalRecruitingStaffing Agency
Hiring Manager
Angelica Murphy🧬🧫
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
Qualification
Required
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
Preferred
Willingness to travel approximately 10–15%
Benefits
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
Company
BioPhase
BioPhase Solutions specializes in staffing and recruiting professionals for pharmaceutical, biotech and medical device companies.
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase