Vertex Pharmaceuticals Incorporated
Boston, MA, USA
Job Description The Audit Management Associate Director is responsible for managing audit and inspection activities, including internal and external processes. This role involves designing and executing compliance audits across GMP suppliers through a risk-based audit program supporting Vertex's business functions. The role ensures adherence to regulations, industry standards, and Vertex policies, procedures, and quality standards as outlined in the Quality Management System. It may focus on manufacturing, distribution, laboratory, or clinical practices, applying specialized domain knowledge and providing technical recommendations to management. Key Duties and Responsibilities: Provide expertise and leadership in Medical Device / Combination Product Regulation. Contribute to the direction, performance, and effectiveness of the GMP audit program, ensuring quality risk management and compliance. Partner with QA leadership and business leaders to coordinate and align audit...