The Supplier Quality Manager will be a key part of the Quality Assurance team and will be responsible for Supplier, Material Assessment, Service Provider an Approval in readiness for product licence approval and commercial manufacture. You will have 1 direct report to manage in this role.
The company is creating cutting – edge therapies to help change people’s lives in their state-of-the-art GMP manufacturing facility in Edinburgh.
The Role:
You will maintain a robust, risk – based process for supplier and material assessment and approval, to ensure compliance with regulatory requirements.
- Routine management, oversight, and reassessment of approved Suppliers, Service Providers and Materials.
- Developing a robust back-up critical supplier strategy in collaboration with Supply Chain and MSAT teams.
- Continuous development of the existing Supplier, Service provider and material assessment process to ensure compliance with all relevant regulatory requirements.
- Creation, execution, and management of Supplier Quality & Technical Agreements for relevant GMP Suppliers and Service providers
- Developing the existing supplier complaint procedure and align to the criticality of the business
- Management of Supplier change notifications via the Change Management process
- Assuring up to date Melamine and sterility assessments SAL (10-6). Arranging bespoke evaluation and testing if required.
- Assuring up to date TSE assessments (to 2nd level) and E & L assessments. Arrange bespoke evaluation and testing if required.
- Preparing Supplier Quality Risk Assessments and providing supporting documentation to the Regulatory Agencies (formal written responses and at inspection).
- Rolling out training in new and updated systems.
- Developing and managing vendor complaints process including investigations and follow-up.
- Completing any other quality related documentation including change controls, incidents/deviations and risk assessments in accordance with GMP and standard operating procedures relating to the role.
Experience:
This role would be well suited for someone who has experience in Supplier Management in a GMP environment, ideally biologics, pharmaceuticals or medical device manufacture. This role would be fast paced, and no two days are the same.
- Strong demonstrated knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment.
- Lead auditor certified
- Experience of leading investigations, particularly those associated with vendor complaints.
- Demonstrated experience working cross-functionally and leading significant improvement initiatives.
- Understanding of sterile manufacturing requirements.
- Preferably Green Belt certified with experience of implementation of Lean Six Sigma tools
- Ability to handle multiple priorities in a dynamic environment.
- Background of technical RCA and FMEA techniques.