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Vice President, Head of Quality (GxP)
A growing, innovative biopharmaceutical company is seeking an experienced Vice President, Head of Quality to lead its global GxP Quality organization. Reporting to the SVP, Chief Financial Officer, this executive will oversee the development and execution of comprehensive quality systems, ensuring compliance across all GxP-related functions and external partnerships.
Key Responsibilities
- Develop and lead a high-performing Quality organization aligned with company goals and regulatory expectations
- Oversee global GxP compliance, including oversight of CROs, CDMOs, CTLs, and other third-party partners
- Set the strategic vision for Quality and drive a culture of continuous improvement and compliance
- Ensure robust quality systems are implemented and maintained to support all phases of product development and lifecycle
- Lead regulatory inspection readiness and responses, audit management, and quality risk mitigation initiatives
Qualifications
- 15+ years in pharmaceutical/biotech industry, including drug substance/product manufacturing and development
- 15+ years of leadership experience managing internal and external Quality functions
- Bachelor’s or advanced degree in a life sciences discipline
- Expertise in global GxP standards, ICH guidelines, EU directives, and Swiss MPLO
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