Facility Compliance Lead: GMP, Audits & Risk Champion

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

Job summary

Norgine is seeking a Facility Compliance Lead to provide leadership and governance for Engineering Compliance across the site, ensuring facilities, utilities, maintenance, calibration and documentation meet regulatory and quality requirements.

You will drive inspection readiness, manage compliance risks and push continuous improvement with the Engineering Compliance team, while coordinating with Quality on CAPAs and audits.

Qualifications

• Strong experience within engineering, facilities or quality compliance in a regulated environment.
• In-depth understanding of engineering standards and compliance.
• Strong knowledge of relevant policies, regulations and quality management principles.
• Experience supporting regulatory and customer audits, with knowledge relevant to GMP, FDA, MHRA and ISO requirements.
• Experience managing maintenance, calibration, compliance or PPM systems.
• Knowledge of quality assurance, project quality management and compliance systems.
• Strong risk management, investigation and continuous improvement capabilities.
• Experience supervising and directing people and resources to deliver results within defined timescales.
• Computer literacy, including working knowledge of Microsoft Office and a PPM system.
• Strong communication, stakeholder management, planning and decision-making skills.

Responsibilities

• Lead the site's Facility Compliance programme, setting compliance priorities, governance and improvement strategies.
• Lead and develop the Engineering Compliance team, maintaining high standards of accountability and capability.
• Oversee preventive maintenance and calibration programmes to ensure activities stay on schedule and compliant.
• Act as the Engineering representative during audits, inspections and regulatory reviews.
• Monitor compliance performance through KPIs and governance reporting, identifying risks.
• Maintain oversight of engineering quality systems, procedures, records and controlled documentation.
• Own CMMS governance, data integrity and compliance.
• Lead investigations, risk assessments, change controls and corrective actions.
• Work with Quality on CAPAs, audit observations and remediation activities.
• Provide compliance oversight for facility improvements, remediation and capital projects.
• Ensure contractor activities meet safety, quality and compliance standards.

Skills

Engineering compliance

Risk management

Regulated environment

Stakeholder management

Audits

Tools

Microsoft Office

PPM system

Job description

Norgine is seeking a Facility Compliance Lead to provide leadership and governance for Engineering Compliance across the site, ensuring facilities, utilities, maintenance, calibration and documentation meet regulatory and quality requirements.

You will drive inspection readiness, manage compliance risks and push continuous improvement with the Engineering Compliance team, while coordinating with Quality on CAPAs and audits.