Vice President, Quality Assurance - GMP

Role: Vice President, Quality Assurance - GMP, responsible for leading enterprise GMP QA strategy, ensuring compliance across clinical and commercial manufacturing, and serving as final product disposition authority. Responsibilities include overseeing GMP QA functions, managing inspections and audits (including FDA and third-party), developing quality agreements, and ensuring regulatory compliance of clinical and commercial materials. The role involves partnering with manufacturing, supply chain, and external vendors, and leading investigations, root cause analyses, and risk assessments. Leadership duties encompass talent development, organizational structure, and cross-functional governance. Qualifications: BS/BA with 21+ years, MS/MA with 19+ years, or PhD with 17+ years in biopharma, with extensive GMP QA industry experience, including regulatory inspections and external manufacturing oversight. Skills include deep knowledge of global GMP regulations, strong leadership, strategic thinking, risk-based decision-making, and effective communication with regulatory bodies. High-value specifics: senior leadership in GMP Quality Assurance within biotech/pharma, experience with regulatory inspections, with a focus on clinical and commercial GMP operations, and cross-functional collaboration. Work setup: likely hybrid or on-site, with no specific travel requirements stated.