Operations QA Compliance Manager - 12 month FTC

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

Job summary

Norgine is seeking an experienced Operations QA Compliance Manager to lead quality oversight across the Hengoed manufacturing site, ensuring safe, effective and compliant products for patients.

Reporting to the Quality organisation, you will drive cGMP compliance, oversee deviations and CAPAs, manage audits and inspections, and develop a high-performing team across operations, engineering and cross-functional partners.

Qualifications

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

Quality Assurance

cGMP knowledge

CAPA management

Change control

Root cause analysis

Validation

Qualification

Engineering compliance

Leadership

Data analysis

Education

Degree in scientific/ pharmaceutical/ engineering or related discipline

Job description

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.

Requirements

Key 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.

Essential

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.

AI transparency statement: AI-assisted drafting may be used to support the creation of clear and engaging adverts. Every advert is reviewed and approved by the recruitment team before publication.

Benefits

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