Quality Control Director

Job description

Job Description General Summary: The External Manufacturing Director – Quality Control (ExM-QC) will lead the strategic and technical oversight of Quality Control (QC) activities to ensure the highest standards of product quality and compliance for Vertex’s biologics and combination device product across development, PPQ, launch, and commercial lifecycle. This role is pivotal in driving QC excellence, fostering collaboration with internal and external stakeholders, and ensuring adherence to cGMP regulations. Reporting directly to the head of ExM-QC small molecule and biologics, the Director will play a critical role in shaping QC strategies, managing external partnerships, overseeing investigations and supporting regulatory submissions. Key Duties and Responsibilities: - Define and implement QC strategies and systems to ensure product quality and compliance for biologics and combination device products - Ensure success of Quality Control function through strategic and scientific leadership. Develop and lead strong collaborative relationships with internal and external teams and build technical knowledge within the group - Manage priorities and oversee QC related activities includin...