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Quality Assurance Manager - Cdmo

Company

Mantell Associates

Address United States
Employment type FULL_TIME
Salary
Category Biotechnology Research,Pharmaceutical Manufacturing
Expires 2023-08-31
Posted at 8 months ago
Job Description

Mantell Associates is partnered with a rapidly growing CDMO who are seeking a Manager of Quality Assurance to join their talented team.


Quality Assurance Manager - Responsibilities:

  • Reviews and approves QC stability study summaries, protocols, and final reports
  • Develop and oversee the Quality on the Floor Program responsible for visual inspection and packaging operations
  • Oversee the New Product Introduction (NPI) process responsible for onboarding new customers and products to ensure successful clinical and commercial drug product manufacturing
  • Provide strategic guidance to resolve complex investigations and product quality issues
  • Reviews and approves Commissioning and Validation protocols and final reports
  • Lead the Product Quality Team responsible for disposition of batches, tracking batch release, and partnering with other departments to close out all required deliverables to support product disposition


Quality Assurance Manager - Requirements:

  • Team player with exceptional communication skills, a concern for excellence, ability to develop and mentor a team, and a high ability to collaborate with various levels of the organisation
  • Proven experience managing a team
  • GMP compliance knowledge
  • Able to efficiently prioritise workload across the team
  • Scientific degree and strong experience in Quality Assurance leadership in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility


Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.