ED/VP/Head of Quality

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.