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:
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.