Associate Vice President, External Quality
Confidential
Associate Vice President, External Quality
About the Company
Industry shaping pharmaceutical company
Industry
Pharmaceuticals
Type
Public Company
Founded
1891
Employees
10,001+
Categories
- Biotechnology
- Health Care
- Medical
- Pharmaceuticals
- Biotechnology and Pharmaceuticals
- Drug Manufacturing & Research
- Healthcare
Specialties
- pharmaceutical
Business Classifications
- B2C
- E-Commerce
About the Role
The Company is seeking a Head of External Manufacturing Quality for Large Molecules. This senior leadership role is responsible for directing a global team and establishing the quality strategy, governance, and oversight model for products manufactured, tested, packaged, released, stored, and distributed through the external manufacturing network. The successful candidate will ensure compliance with the company's requirements, regulatory expectations, and global GMP standards, while also supporting reliable supply, timely product launches, and the execution of technology transfers across multiple external manufacturing sites. Key responsibilities include leading the quality oversight of external manufacturing partners, driving timely product release, and leading major quality investigations. The role also involves providing quality leadership for critical milestones, strengthening partner readiness, and maintaining a risk-based quality oversight framework. Candidates for this role at the company should have a Bachelor’s degree in a scientific discipline, with an advanced degree preferred, and a minimum of 10 years' experience in quality systems, quality assurance, and/or quality control within pharmaceutical manufacturing operations. The ideal candidate will have a strong background in compliance, experience with biologics and vaccines manufacturing, and a proven track record in managing complex quality investigations. Required skills include auditing, cGMP compliance, and a strong understanding of quality governance models. The role demands a leader with the ability to influence, drive change, and foster a culture of operational excellence and proactive problem-solving. Experience in strategic planning, and the ability to build and maintain effective quality systems, are also essential.
Hiring Manager Title
Vice President of Quality, Global Biologics
Functions
- Operations
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