Executive Director, Quality Assurance

Role: Lead strategic oversight of a global enterprise-level transformation program within manufacturing quality, focusing on digital and analytical innovations in GMP laboratories. Objectives include transforming QC testing processes, integrating end-to-end digitization, lab automation, and standardized workflows to enhance compliance and operational efficiency. Responsibilities encompass managing program planning, governance, stakeholder collaboration across cross-functional teams, and overseeing execution from planning to regulatory filing and operational transition. The role involves ensuring alignment with GxP and regulatory standards while driving technology adoption and continuous improvement. Requirements include a bachelor’s degree (advanced degree preferred), 15+ years in quality or biopharma manufacturing with leadership experience in GMP labs, and expertise in analytical development, automation validation, and regulated environments. Preferred skills include programming, R&D experience, and vendor management. High-value specifics involve familiarity with GxP, analytical testing, lab automation, digital systems, and enterprise transformation within biopharma manufacturing. The position reports to project leadership, involves stakeholder engagement with executive sponsors, and operates in a hybrid work setting with some travel expected.