Mantell Associates
Mantell Associates is partnered with a rapidly growing API 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.