Validation Manager

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

Job summary

Norgine is seeking a Validation Manager to lead the site validation function, ensuring strategies, systems and activities stay compliant, inspection-ready, and aligned with business objectives.

You will provide leadership across validation lifecycle activities, drive continual improvement, oversee deviations and CAPAs, and collaborate with Quality, Operations, Engineering and Regulatory teams.

Qualifications

• Significant experience in the pharmaceutical or medical device industry.
• Proven validation management and project leadership experience.
• Experience leading, coaching, and developing teams.

Responsibilities

• Lead and develop the site validation strategy, programmes, policies, and procedures.
• Ensure validation activities comply with GMP requirements and regulatory expectations.
• Oversee qualification and validation activities for facilities, utilities, equipment and systems.
• Review and approve validation documentation and key deliverables.
• Provide oversight of deviations, investigations, CAPAs, change controls, audits and inspections.
• Monitor validation performance and communicate outcomes to senior stakeholders.

Skills

Quality assurance

Validation management

Risk management

Communication

Decision making

Reporting & presentation

Education

Science/Engineering degree

Tools

GAMP

Job description

Transform Lives Through Innovation At Norgine, we have been transforming patients' lives for over a century. We combine specialist expertise, entrepreneurial thinking, and strong partnerships to bring life-changing healthcare solutions to patients across Europe. We encourage our people to Drive, Dare, and Develop every day, creating an environment where innovation, collaboration, and continuous improvement thrive.

The Role

We are looking for a Validation Manager to lead the site validation function, ensuring validation strategies, systems, and activities remain compliant, inspection-ready, and aligned with business objectives. This role provides leadership, governance, and technical expertise across validation lifecycle activities while driving continuous improvement and regulatory compliance.

Key Responsibilities

• Lead and develop the site validation strategy, programmes, policies, and procedures.
• Ensure validation activities comply with GMP requirements, regulatory expectations, and industry best practice.
• Oversee qualification and validation activities for facilities, utilities, equipment, computerised systems, cleaning processes, and manufacturing processes.
• Review and approve validation documentation and key deliverables.
• Provide oversight of deviations, investigations, CAPAs, change controls, audits, and inspections.
• Monitor validation performance, identify risks and improvement opportunities, and communicate outcomes to senior stakeholders.
• Build strong partnerships across Quality, Operations, Engineering, and Regulatory functions.

Experience

• Significant experience within the pharmaceutical or medical device industry.
• Proven validation management and project leadership experience.
• Experience leading, coaching, and developing teams.
• Strong knowledge of validation lifecycle management and quality systems.
• Working knowledge of ICH Q8, ICH Q9, GAMP, cGMP, and EU/FDA regulatory requirements.

Skills

• Quality assurance and validation expertise.
• Risk management and analytical problem-solving skills.
• Strong communication, influencing, and stakeholder management abilities.
• Ability to make sound decisions in complex environments.
• Effective reporting, negotiation, and presentation skills.
• Commitment to continuous improvement and operational excellence.

Qualifications

• Degree equivalent in a scientific or engineering discipline such as Chemistry, Biology, Process Engineering, Pharmaceutical Sciences, or Medical Technology.

Success at Norgine means living our values

Drive: Take ownership, deliver results, and apply business insight to achieve meaningful outcomes.

Dare: Challenge constructively, embrace innovation, and demonstrate courage when tackling complex issues.

Develop: Collaborate effectively, value different perspectives, and help build the capability of others.

Why Norgine?

Join a company that encourages multidimensional careers where you can grow professionally, contribute to meaningful healthcare outcomes, and work alongside talented colleagues who are passionate about improving patients' lives.

This advert summarises the key responsibilities of the position and is not exhaustive. Norgine may adjust responsibilities to meet business and organisational needs.