1. Manage the Quality System in strict compliance with ISO and cGMP standards and regulations
2. Provide mentorship, promoting these standards throughout the company
3. Lead, empower, and guide the Quality Assurance and Quality Control teams
4. Stay current with regulatory requirements, particularly cGMP and the European/United States Pharmacopeia standards
5. Discuss regulatory requirements with management and liaise with customers as needed
6. Coordinate critical review of product batch records before final product release
7. Manage the validation process in accordance with regulatory guidelines
8. Host and manage customer audits, ensuring corrective actions are completed
9. Handle the Customer Complaints system efficiently
10. Review quality agreements internally to determine their implications and ensure compliance with customer requirements
11. Manage the Supplier Quality audit programme and implement quality agreements for suppliers
12. Provide technical assistance to the Commercial team and other internal departments
13. Operate within departmental capital and expense budgets
14. Ensure H&S compliance in line with UK legislation within the remit of the role
15. Perform any other tasks as deemed appropriate by the site or Quality leadership
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