Facility Compliance Lead: Engineering & Quality

Norgine B.V.; Cefn Hengoed; On-site; GBP 65,000 - 90,000; Full time

Job summary

Norgine B.V. is seeking a Facility Compliance Lead to provide leadership and governance for Engineering Compliance across the site.

You will ensure facilities, utilities, maintenance, calibration, engineering systems, documentation and contractor activities meet regulatory, quality and business requirements, driving inspection readiness and continuous improvement. You will lead the Facility Compliance programme, develop the Engineering Compliance team and oversee audits, KPIs and risk-based

Qualifications

• Experience in engineering, facilities or quality compliance within a regulated environment.
• Strong knowledge of engineering standards and compliance practices.
• Familiarity with GMP, FDA, MHRA or ISO quality management principles.
• Experience supporting regulatory audits and customer inspections.

Responsibilities

• Lead the site's Facility Compliance programme, setting governance and improvement strategies.
• Develop and coach the Engineering Compliance team to high standards.
• Oversee preventive maintenance and calibration programmes for compliance.
• Represent Engineering during audits, inspections and regulatory reviews.
• Monitor KPIs and governance reporting to identify emerging risks.
• Maintain engineering quality systems, records and controlled documentation.
• Own CMMS governance and data integrity.
• Lead investigations, risk assessments, change controls and CAPAs.
• Collaborate with Quality on CAPAs and remediation activities.
• Provide compliance oversight for facility improvements and capital projects.
• Ensure contractor activities meet safety, quality and compliance standards.

Job description

Norgine B.V. is seeking a Facility Compliance Lead to provide leadership and governance for Engineering Compliance across the site.

You will ensure facilities, utilities, maintenance, calibration, engineering systems, documentation and contractor activities meet regulatory, quality and business requirements, driving inspection readiness and continuous improvement. You will lead the Facility Compliance programme, develop the Engineering Compliance team and oversee audits, KPIs and risk-based