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.