Lead Validation & GMP Compliance 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

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.