Executive Director, Quality Assurance
Core
Strategic oversight and direction for an enterprise-level transformation program to transform QC testing, analytical digitization, lab automation, and QMS systems within a GMP laboratory.
Role type
Executive Director, Quality Assurance (Transformation & Strategy)
Builds
Scalable, compliant, and future-ready analytical and quality operating models for pipeline and in-line supply products.
Domain
Biopharmaceutical manufacturing, Quality Assurance, Laboratory Automation, GxP Compliance
Required skills
Strategic program leadership, GxP/GMP compliance, Analytical development and testing, Laboratory automation and instrumentation, Cross-functional program governance, Risk management, Budgeting and financial acumen, Stakeholder management, Regulatory filing support, Change management
Preferred skills
PhD/MBA/PharmD, R&D experience in clinical phases, Workforce strategy, Third-party technology provider management, Stage gate governance models
Technologies
QMS systems, Lab automation systems, Analytical instrumentation, IT/Program environments
Responsibilities
Oversee integrated planning, governance, and execution of complex transformation programs; Partner with executive leadership and cross-functional teams to manage interdependencies; Drive technology and operating model transformation; Ensure alignment with quality and regulatory requirements; Direct decision forums to remove barriers and advance programs from planning to operational sustainment.
Seniority
Executive, hands-on IC with strategic oversight