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Quality Manager

Mantell Associates
Florida, NY Full Time
POSTED ON 4/4/2025
AVAILABLE BEFORE 5/4/2025

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

Quality Assurance Manager - Responsibilities

  • Oversee the New Product Introduction (NPI) process responsible for onboarding new customers and products to ensure successful clinical and commercial drug product manufacturing
  • 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
  • Develop and oversee the Quality on the Floor Program responsible for visual inspection and packaging operations
  • Provide strategic guidance to resolve complex investigations and product quality issues
  • Reviews and approves Commissioning and Validation protocols and final reports
  • Reviews and approves QC stability study summaries, protocols, and final reports

Quality Assurance Manager - Requirements:

  • Scientific degree and strong experience in Quality Assurance leadership in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility
  • Proven experience managing a team
  • GMP compliance knowledge
  • Able to efficiently prioritise workload across the team
  • 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

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.

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