Clinical QA Manager - CRO

Posted 03 November 2023
Salary Negotiable
LocationNew Jersey
Job type Full Time
Discipline CRO & Clinical Operations
Contact NameLewis Davis

Job description

Mantell Associates is partnered with an established and rapidly growing CRO organisation who are seeking a Clinical Manager of Quality Assurance to join their talented team.

Clinical 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

  • Review and approve Commissioning and Validation protocols and final reports

  • Review and approve QC stability study summaries, protocols, and final reports

Clinical Quality Assurance Manager - Requirements:

  • Scientific degree and strong experience in Quality Assurance leadership in a GCP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility

  • CRO experience required

  • GCP 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.