Facilities Compliance Lead: Engineering & Audit Readiness

Norgine; Hengoed; On-site; GBP 70,000 - 110,000; Full time

Job summary

Norgine is seeking a Facility Compliance Lead to provide leadership and governance for engineering compliance across the site. You will drive inspection readiness, manage compliance risks and lead continuous improvement while coordinating with Quality on CAPAs and remediation.

The role oversees maintenance, calibration, documentation and contractor activities, ensuring alignment with GMP, regulatory expectations and internal standards.

Qualifications

• Experience in engineering, facilities or quality compliance within a regulated environment.
• Strong knowledge of engineering standards, compliance and regulatory expectations.
• Experience supporting regulatory and customer audits (GMP/FDA/MHRA/ISO).
• Experience managing maintenance, calibration, compliance or PPM systems.
• Ability to monitor KPIs, trends and governance reporting.
• Proven ability to lead teams and manage resources to deadlines.

Responsibilities

• Lead the site's Facility Compliance programme, setting priorities and strategies.
• Develop the Engineering Compliance team and maintain high accountability.
• Oversee preventive maintenance and calibration to stay within schedules and tolerances.
• Act as Engineering representative during audits, inspections and regulatory reviews.
• Monitor compliance performance with KPIs and governance reporting; escalate risks.
• Maintain documentation, records and CMMS data governance.
• Lead investigations, risk assessments, change controls and CAPAs.
• Collaborate with Quality on CAPAs and remediation activities.
• Provide oversight for facilities improvements and capital projects.
• Ensure contractor activities meet safety, quality and compliance standards.

Skills

Engineering compliance

Facilities management

Quality compliance

Audits & regulatory

Risk management

Stakeholder management

Tools

MS Office

PPM systems

Job description

Norgine is seeking a Facility Compliance Lead to provide leadership and governance for engineering compliance across the site. You will drive inspection readiness, manage compliance risks and lead continuous improvement while coordinating with Quality on CAPAs and remediation.

The role oversees maintenance, calibration, documentation and contractor activities, ensuring alignment with GMP, regulatory expectations and internal standards.