Senior Manager, GMP Inspection Readiness

Job description

Job Description GENERAL/POSITION SUMMARY: The Senior Manager, GMP Inspection Readiness plays a key role in ensuring ongoing inspection readiness across Vertex and our manufacturing network. This individual will lead and enhance real-time GMP inspection readiness activities for Contract Manufacturing Organizations (CMOs) spanning multiple modalities, including Small Molecule, Cell & Gene Therapies, Biologics, and Medical Devices. Responsibilities include developing and managing readiness plans, overseeing key deliverables and metrics, identifying and mitigating risks, and supporting regulatory inspections from the preparation stage through follow-up activities. This role requires strong project management, strategic thinking, and the ability to work effectively across a broad range of stakeholders in a fast-paced environment. As a recognized subject matter expert in GMP quality, compliance, and quality systems, the Senior Manager will partner closely with internal teams and external manufacturing organizations to help maintain a continuous state of readiness, support global expansion initiatives, and drive continuous improvement of inspection readiness tools, processes, and programs...