Senior Quality Assurance Manager - CDMO

Posted 01 August 2023
Salary Negotiable
LocationUnited States of America
Job type Full Time
DisciplineLarge Molecule
Contact NameChristopher Gomez

Job description

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

Senior Quality Assurance Manager - Responsibilities:

  • Develop and oversee the New Product Introduction (NPI) process responsible for onboarding new customers and products to ensure successful clinical and commercial drug product manufacturing

  • Develop and oversee 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

Senior 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 prioritize 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 organization

Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +1 (786) 245-8592.