Operations QA & Compliance Leader

Norgine; Hengoed; On-site; GBP 65,000 - 90,000; Full time

Job summary

Norgine in the United Kingdom is seeking an experienced Operations QA Compliance Manager to lead quality oversight across our Hengoed site and help ensure the delivery of safe, compliant products for patients.

Reporting into the Quality organisation, you will drive cGMP adherence, manage deviations, CAPAs, change controls and quality investigations, and develop a high-performing team while partnering with Operations and Engineering to strengthen site-wide quality performance.

Qualifications

• Degree in a scientific, pharmaceutical, engineering or related discipline.

Responsibilities

• Lead Quality Assurance oversight of manufacturing operations and provide expert GMP guidance.
• Manage deviations, CAPAs, change controls, risk assessments and quality investigations.
• Ensure batch documentation and quality records remain compliant and inspection-ready.
• Oversee quality compliance of engineering systems, utilities and validation activities.
• Monitor quality performance metrics and drive continuous improvement initiatives.
• Support regulatory inspections, audits and licence-to-operate requirements.
• Lead, coach and develop a high-performing team, ensuring effective training and capability development.

Skills

Quality Assurance leadership

GMP knowledge

Root cause analysis

CAPA management

Change control

Regulatory inspections

Data analysis

Communication skills

Team leadership

Education

Degree in scientific, pharmaceutical, engineering or related discipline

Tools

Validation and qualification principles

Calibration practices

Job description

Norgine in the United Kingdom is seeking an experienced Operations QA Compliance Manager to lead quality oversight across our Hengoed site and help ensure the delivery of safe, compliant products for patients.

Reporting into the Quality organisation, you will drive cGMP adherence, manage deviations, CAPAs, change controls and quality investigations, and develop a high-performing team while partnering with Operations and Engineering to strengthen site-wide quality performance.