Quality Systems And Compliance Manager

Walker Cole International Ltd; Beckingthorpe; On-site; GBP 70,000 - 90,000; Full time

Job summary

Walker Cole International Ltd. is supporting a well-established healthcare and life sciences organisation in the search for a Quality Systems and Compliance Manager to join their team, based in the East Midlands.

The role will own the Quality Management System, ensure EU/UK GMP and GDP compliance, and keep the site audit-ready at all times. You will lead a three-person team and drive improvements across document control, quality data and audits.

Qualifications

• Degree in Life Sciences or equivalent experience in quality facilitation, process improvement or quality data analysis.
• Experience in pharmaceuticals, medical devices, biotechnology or a similar regulated industry.
• Strong knowledge of Quality System processes and EU/UK GMP.
• Experience with document control, internal audit, CAPA, nonconformance and complaints processes.
• Experience with problem-solving tools such as 8D, Gemba, 5 Whys and cause and effect analysis.
• Strong communication, coordination and people management skills, with excellent attention to detail and organisational ability.

Responsibilities

• Owning the Quality Management System and ensuring compliance with EU/UK GMP and GDP requirements.
• Ensuring all controlled documentation is current, accurate and accessible, and reviewing and approving new and updated procedures.
• Ensuring quality records are complete, legible and compliant with good documentation practice.
• Tracking, trending and monitoring quality data, including CAPAs, complaints and deviations, to ensure timely completion..
• Leading internal audits and coordinating responses to external, regulatory and customer audits.
• Driving investigation of audit findings and ensuring corrective actions are delivered promptly and effectively.
• Championing risk identification and management across the unit.
• Managing and developing a team of three, and driving continuous improvement by reducing waste and variation.

Skills

Quality management

Regulatory compliance

Leadership

Quality data analysis

Risk management

Education

Degree in Life Sciences

Job description

Walker Cole International is supporting a well-established healthcare and life sciences organisation in the search for a Quality Systems and Compliance Manager to join their team, based in the East Midlands.

This is an excellent opportunity to lead the Quality Systems and Compliance function, supplying medicines that directly support patient care. You will own the Quality Management System, ensuring the site meets GMP and GDP requirements and remains audit-ready at all times. The role offers broad leadership exposure across document control, quality data and KPIs, risk management and internal and external audits.

This role would suit an experienced quality professional with strong QMS knowledge and people management experience, who is looking to lead and develop a team of three in a full-time, site-based role.

You will be responsible for:

• Owning the Quality Management System and ensuring compliance with EU/UK GMP and GDP requirements.
• Ensuring all controlled documentation is current, accurate and accessible, and reviewing and approving new and updated procedures.
• Ensuring quality records are complete, legible and compliant with good documentation practice.
• Tracking, trending and monitoring quality data, including CAPAs, complaints and deviations, to ensure timely completion..
• Leading internal audits and coordinating responses to external, regulatory and customer audits.
• Driving investigation of audit findings and ensuring corrective actions are delivered promptly and effectively.
• Championing risk identification and management across the unit.
• Managing and developing a team of three, and driving continuous improvement by reducing waste and variation.

The successful candidate will have:

• A degree in a relevant Life Sciences discipline, or equivalent experience in quality facilitation, process improvement or quality data analysis.
• Experience within pharmaceuticals, medical devices, biotechnology or a similar regulated industry.
• Strong knowledge of Quality System processes and a working knowledge of EU/UK GMP.
• Experience in document control, internal audit, CAPA, nonconformance and complaints processes.
• Experience with problem-solving tools such as 8D, Gemba, 5 Whys and cause and effect analysis.
• Strong communication, coordination and people management skills, with excellent attention to detail and organisational ability.

Quality Systems Manager | Compliance Manager | Quality Assurance | QA | QMS | GMP | GDP | EU GMP | UK GMP | Aseptic | Document Control | Internal Audit | CAPA | Deviations | Complaints | Risk Management | Continuous Improvement | Pharmaceutical