Senior Operations QA & Compliance Leader

Norgine B.V.; Cefn Hengoed; On-site; GBP 70,000 - 110,000; Full time

Job summary

Norgine is seeking an experienced Operations QA Compliance Manager to lead quality oversight across our Hengoed site, ensuring safe, effective and compliant products for patients. Reporting into the Quality organisation, you will provide leadership for operational QA activities across manufacturing and engineering operations.

You will drive investigations, CAPAs, change controls, and inspections readiness while developing a high-performing team and partnering with cross-functional stakeholders

Qualifications

• Degree in a scientific, pharmaceutical, engineering or related discipline.
• Significant experience within pharmaceutical quality assurance, manufacturing or compliance.
• Strong knowledge of cGMP regulations and pharmaceutical quality systems.
• Experience leading investigations, root cause analysis, CAPA management and change control processes.
• Working knowledge of validation, qualification, calibration and engineering compliance requirements.
• Proven ability to lead teams, influence stakeholders and drive continuous improvement.
• Strong planning, data analysis, written and verbal communication skills.

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.
• Partner with Operations, Engineering and cross-functional stakeholders to strengthen quality performance across the site.

Skills

QA leadership

GMP compliance

Deviations & CAPA management

Change control

Root cause analysis

Cross-functional collaboration

Data analysis

Communication skills

Education

Degree in scientific_pharma_engineering_or_related

Tools

cGMP knowledge

Validation & qualification

Engineering compliance

Audit readiness

Job description

Norgine is seeking an experienced Operations QA Compliance Manager to lead quality oversight across our Hengoed site, ensuring safe, effective and compliant products for patients. Reporting into the Quality organisation, you will provide leadership for operational QA activities across manufacturing and engineering operations.

You will drive investigations, CAPAs, change controls, and inspections readiness while developing a high-performing team and partnering with cross-functional stakeholders