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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
Confidential
Vacancy posted 20 hours ago
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