Executive Director, Development Quality
Confidential
Executive Director, Development Quality
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 Development Quality. This pivotal role is responsible for providing strategic and operational quality leadership across all therapeutic areas, with a focus on development programs from first-in-human to lifecycle management. The successful candidate will be a quality champion, engaging with a diverse range of professionals to drive a right-first-time quality culture and continuous improvement mindset. Key responsibilities include defining and driving the quality oversight strategy, serving as a senior quality business partner, and ensuring GxP compliance, inspection readiness, and quality culture across the program portfolio. The role also involves leading quality investigations, root cause analysis, and CAPA management for quality events, as well as overseeing the quality of CMC and LCM activities. 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 pharmaceutical or biotech industry experience, including at least 10 years in quality roles. The ideal candidate will have a deep knowledge of GCP, GVP, and other GxPs, and a proven track record in leading or managing regulatory authority inspections. Experience in regulatory activities, including IND/NDA/MAA and post-approval CMC change management, is essential. The role requires exceptional leadership, strategic thinking, and technical quality expertise, as well as strong stakeholder management and the ability to influence at senior levels. A continuous improvement mindset and the ability to deliver quality outcomes on time are also key competencies for this position.
Hiring Manager Title
VP, R&D Quality
Functions
- Operations
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