Quality Systems Manager

Walker Cole International is searching for a Quality Systems Manager to join a Cell & Gene Therapy business based in Scotland. This candidate will work closely with the Quality Director to coordinate Quality activities across the site, with a strong focus on the Quality Management System (QMS)

You will be responsible for:

• Developing, maintaining and improving the QMS, including CAPAs, root cause analysis and deviations
• Manage the Quality Systems team, ensuring team members are well trained in regulatory compliance activities
• Provide regular reports on QMS KPIs and risk deficiencies
• Deputising for the Head of Quality when needed

The successful candidate will have:

• A BSc (or equivalent) within the Life Sciences, Biotech, Pharmacy or related field
• Prior experience leading continuous improvement projects
• A strong knowledge and understanding of cGMP regulations and Quality Management Systems
• Prior experience hosting audits and inspections

Quality Assurance | QA | Pharmaceutical | CAPA | Corrective and Preventative Action | Quality | Batch Release | GMP | Good Manufacturing Practice | Operational | IMP | Investigational Medicinal Product | Commercial | Sterile | Biopharmaceutical | ATMP | Advanced Therapy Medicinal Product | QMS | Quality Management System |