Manufacturing Compliance Team Leader - Oxford
Oxford, England, United Kingdom
The Manufacturing Compliance Team Leader manages day-to-day activities at the manufacturing center. Responsibilities include planning, performing, and documenting in-process testing, including calibration and compliance for all manufacturing activities. Reporting directly to the QC Manager, this role aligns closely with the Operations departments. The following major responsibilities and key tasks are listed, though the role may include other tasks as requested by the QC Manager. This position is based on-site to ensure effective control of manufacturing and service documentation and collaboration with both Operations and Quality teams.
Major Responsibilities
Under the QC Manager's direction, the Manufacturing Compliance Team Leader will:
Ensure GDP/GMP compliance within Manufacturing QC areas through inspection of subassemblies and finished products.
Create and maintain manufacturing in-process and final release inspection procedures and work instructions.
Manage the Quality Manufacturing team, ensuring timely approval and release of spare parts, subassemblies, and finished products.
Drive initiatives for measurable performance improvements.
Develop processes, procedures, and work instructions in the area of expertise.
Improve compliance adherence to the documented Quality System.
Act as a Subject Matter Expert by maintaining knowledge of relevant procedures and specifications, including supporting external audits (e.g., BSI, FDA).
Skills and Experience
Working knowledge of GDP/GMP requirements.
Ability to create and write Standard Operating Procedures and Work Instructions/Specifications.
Understanding of inspection criteria and the use of drawings/specifications.
Experience in manufacturing for medical devices.
Knowledge of SAP (desirable).
Knowledge of Master Control or other eQMS.
Strong written and oral communication skills.
Good understanding of GMP compliance requirements in Quality Control.
Attention to detail.
Promotes a collaborative working environment.
Understanding of using basic measurement tools (e.g., calipers/jigs and gauges).
Apply or contact me directly at [email protected]