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Job description
Executive Director / VP, Head of Quality Assurance
FULLY ONSITE IN CALIFORNIA
We are seeking an experienced and strategic Quality Assurance leader to drive and oversee GxP compliance, quality systems, and operational excellence across all stages of drug development. This individual will serve as a key member of the leadership team, ensuring that quality standards support safe, effective, and compliant product development and commercialization.
Key Responsibilities:
Provide leadership and strategic direction for the Quality Assurance function, ensuring compliance with global GxP regulations
Develop, implement, and maintain robust quality systems and processes across clinical and commercial operations
Oversee audits, inspections, and vendor/partner quality oversight programs
Lead quality risk management and continuous improvement initiatives
Collaborate cross-functionally with R&D, Manufacturing, Regulatory, and Clinical teams to ensure quality standards are integrated throughout development
Review and approve quality-related documentation, including SOPs, policies, deviations, CAPAs, and regulatory submissions
Serve as the primary quality liaison with regulatory authorities during inspections and submissions
Mentor and develop QA staff, promoting a culture of accountability and quality excellence
Qualifications:
Advanced degree in Life Sciences, Pharmacy, or related field preferred
10+ years of Quality Assurance experience in the biopharmaceutical industry, with increasing leadership responsibility
Strong knowledge of GxP regulations, FDA, EMA, and other global regulatory requirements
Proven experience leading quality systems for clinical and commercial operations
Excellent leadership, communication, and interpersonal skills
Track record of successfully managing inspections, audits, and quality compliance programs
Strategic thinker with the ability to influence at senior leadership levels
This is an exceptional opportunity for a seasoned QA professional to lead quality strategy at a growing, innovative biopharmaceutical company.
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Worksite address
california, MO, 65018, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.