Walker Cole International is searching for a Quality Director to join a well-established pharmaceutical manufacturing business with on-site operations in the UK. As the Quality Director, you will lead the site Quality function, providing strategic and operational oversight across both Quality Assurance and Quality Control teams while ensuring the site operates in full compliance with GxP requirements.
Your responsibilities will include:
- Providing strategic leadership across the site QA and QC functions, ensuring compliance with cGMP and EU GMP requirements.
- Leading and developing Quality teams while embedding a strong quality culture across manufacturing and laboratory operations.
- Overseeing key Quality Systems including deviations, CAPAs, investigations, change controls, and batch disposition activities.
- Acting as the senior Quality representative during regulatory inspections, customer audits, and internal compliance reviews.
- Partnering closely with Manufacturing, Engineering, and Supply Chain teams to support operational performance and continuous improvement initiatives.
The successful candidate will demonstrate the following:
- Extensive Quality leadership experience within a pharmaceutical manufacturing environment.
- Proven experience managing both QA and QC teams within a regulated GMP facility.
- Strong understanding of pharmaceutical manufacturing operations, investigations, and regulatory compliance expectations.
- Eligibility to act as a Qualified Person (QP) on a Manufacturing Authorisation licence would be highly desirable, though not essential.
- A collaborative and pragmatic leadership style with the ability to influence stakeholders across all levels of the organisation.
Quality Assurance | Quality Control | QA | QC | QP | Qualified Person | GMP | cGMP | Pharmaceutical Manufacturing | CAPA | Deviations | OOS | Batch Release | Audit | Head of Quality | Quality Director | MHRA | EU GMP