Operations QA Compliance Manager - 12 month FTC

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

Transform Lives. Drive Quality. Develop People.

At Norgine, we have been transforming people's lives for over a century through innovative healthcare solutions. We are looking for an experienced Operations QA Compliance Manager to lead quality oversight across our Hengoed manufacturing site and help ensure the delivery of safe, effective and compliant products to patients.

We are a company built on three core values:

• Drive - Take ownership, deliver results and make decisions that matter.
• Dare - Challenge the status quo, embrace innovation and demonstrate courage.
• Develop - Collaborate, value different perspectives and help others reach their potential.

The Role

Reporting into the Quality organisation, you will provide leadership and governance for operational QA activities across manufacturing and engineering operations. You will ensure compliance with cGMP, regulatory requirements and the Pharmaceutical Quality System while promoting a culture of quality, continuous improvement and inspection readiness.

Key Responsibilities

• Lead Quality Assurance oversight of manufacturing operations and provide expert GMP guidance
• Manage deviations, CAPAs, change controls, risk assessments and quality investigationsEnsure 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 & Experience

• 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

Success in this role

You will thrive in this role if you:

• Hold yourself and others accountable for high standards
• Build trust through integrity and sound decision‑making
• Are action‑oriented and comfortable working in complex environments
• Communicate effectively across all levels of the organisation
• Collaborate to achieve shared goals while embracing diverse perspectives

Why Norgine?

At Norgine, we encourage our people to Dare, Drive and Develop. We offer a multidimensional career where you can grow professionally, contribute to meaningful healthcare outcomes and work alongside colleagues who are passionate about making a difference for patients.

Join us and help transform lives through quality, innovation and collaboration.

This advert summarises the key responsibilities of the role and is not exhaustive. Responsibilities may be adjusted to meet business and organisational needs.

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Benefits

Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.