Walker Cole International is searching for a Site Quality Director to join a global Pharmaceutical business with a manufacturing facility in Europe. As the Site Quality Director, you will manage and oversee the Quality functions on site including both Quality Assurance and Quality Control departments. You must be willing to be predominantly site-based and have eligibility to work in the European Union.
Your responsibilities will be to:
- Provide strategic oversight and high-calibre leadership to ensure full compliance with cGMDP and EU regulatory guidelines.
- Champion a culture of quality across the site, ensuring all stakeholders consistently adhere to relevant regulatory standards.
- Collaborate with regional leadership to implement a unified quality strategy across the EMENA region, fostering a harmonised and robust quality culture.
- Serve as the principal liaison with regulatory authorities during GMDP inspections and in all matters pertaining to quality.
- Contribute as a member of the site leadership team, with accountability for quality-related budgeting and resource management.
The successful candidate will demonstrate the following:
- Brings extensive Quality Assurance experience within the pharmaceutical industry, including direct involvement in on-site manufacturing operations.
- Holds the qualifications and experience necessary to be designated as a Qualified Person (QP) and Responsible Person (RP) on the license—highly desirable, though not essential.
- Demonstrates a strong track record in leading and managing complex teams, including those with multi-layered reporting structures.
- Possesses a forward-thinking mindset with the capability to drive change and serve as a pragmatic, solutions-focused quality leader within the organisation.
Quality Assurance | QA | QP | Qualified Person | Deviations | OOS | OOT | GEMBA | GMP | Good Manufacturing Practice | Orange Guide | Small molecule | RP | Responsible Person | Head of Quality | Quality Director | GDP | Good Distribution Practice | Sterile | Aseptic