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.