Executive Director, GxP Quality Center of Excellence
Confidential
Executive Director, GxP Quality Center of Excellence
About the Company
Internationally renowned biopharmaceutical company
Industry
Pharmaceuticals
Type
Public Company
Founded
1858
Employees
10,001+
Categories
- Pharmaceuticals
- Biotechnology
- Biotechnology and Pharmaceuticals
- Health and Wellness
Specialties
- biotechnology
- innovation
- great place to work
- pharmaceuticals
- research and development
- and healthcare
Business Classifications
- E-Commerce
- B2B
- Enterprise
About the Role
The Company is seeking an Executive Director for its GxP Quality Center of Excellence. This strategic leadership role is pivotal in establishing and leading an enterprise-wide GxP quality capability that ensures consistent, data-driven, and risk-balanced practices across R&D and associated functions. The successful candidate will be responsible for integrating various quality aspects, including vendor quality, device quality, GxP inspections, CAPA, and investigation excellence, into a unified operating model. Key responsibilities include driving a risk-balanced, data-driven quality culture, partnering with cross-functional stakeholders to mitigate quality and compliance risks, and championing enterprise-wide quality transformation. The role also involves leading global inspection management, establishing a GxP vendor quality oversight framework, and providing strategic leadership in business development quality. Applicants for this role at the company should have a Bachelor's or higher degree in a scientific discipline, with an advanced degree strongly preferred, and a minimum of 15-20 years of progressive experience in the pharmaceutical or biotech industry, particularly in quality roles. Deep knowledge of GCP, GVP, and other GxPs, as well as a proven track record in leading regulatory authority inspections, is essential. The ideal candidate will have a strong background in organizational transformation, governance, and global program leadership, with a focus on digital innovation and AI-enabled quality transformation. Experience in M&A due diligence and integration, as well as exposure to medical devices, diagnostics, and novel modalities, is a plus. The role requires exceptional leadership, strategic thinking, and the ability to influence and collaborate with senior stakeholders.
Hiring Manager Title
VP, R&D Quality
Functions
- Operations
- Strategy
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