Senior Director of Quality Assurance

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