Senior Director of Quality Assurance

Job Summary

To support a growing biopharmaceutical company, the full-time Senior Director of Quality Assurance will lead the development and implementation of the pharmaceutical quality system, providing independent oversight of product compliance and quality across external partners in a fully remote environment.

Key Responsibilities

• Lead the development and continuous improvement of the company's pharmaceutical quality system, including governance and oversight of quality processes
• Provide independent quality oversight of product manufacturing and testing activities performed by external partners, ensuring compliance with regulations
• Serve as the final quality authority for batch disposition and release, ensuring compliance with market-specific requirements

Required Qualifications

• Bachelor's degree in chemical engineering, pharmaceutical sciences, or a related discipline; advanced degree preferred
• At least 15 years of quality experience in the pharmaceutical or biotechnology industry, with significant leadership responsibility
• Experience leading quality in a substantially outsourced operating model, overseeing CDMOs and other GxP suppliers
• Strong knowledge of global GMP and GDP requirements, including relevant FDA and EMA regulations
• Proven ability to lead regulatory inspections and manage compliance commitments effectively