Senior Director

Job Description

General position summary:

The Sr. Director, RDQA Medical Device and Combination therapies will ensure operational delivery and execution and provide strategic direction and oversight of the device and combination therapy programs within Research and Development QA (RDQA) from the (pre)clinical phases of the product lifecycle through to submission and approval of designated programs across modalities, biologics, medical devices and combination therapies. This role will establish processes and capabilities for effective and proactive quality oversight and risk management across respective product/therapeutic program area(s) (e.g Type 1 Diabetes) This individual will support the Vertex business and Quality Assurance Biologics and Device functions by serving as the resident RDQA Medica Device and combination therapy expert, supporting the appropriate global and local QMS in establishing operational and quality excellence and a constant state of inspection readiness for both products and device across the Vertex portfolio.

This individual will provide strategic oversight and leadership for Quality Management Reviews and spearhead the design and development of...