Facility Compliance Lead

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

The Facility Compliance Lead will provide leadership and governance for Engineering Compliance across the site, ensuring that facilities, utilities, maintenance, calibration, engineering systems, documentation and contractor activities meet regulatory, quality and business requirements. The role will play a key part in maintaining inspection readiness, managing compliance risks and driving continuous improvement.,

• 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 remain within required schedules and compliance tolerances.
• Act as the Engineering representative during internal and external audits, inspections and regulatory reviews.
• Monitor compliance performance through KPIs, trend analysis and governance reporting, identifying and escalating emerging risks.
• Maintain oversight of engineering quality systems, procedures, records and controlled documentation.
• Own CMMS governance, data integrity and compliance.
• Lead compliance investigations, risk assessments, change controls and corrective actions.
• Work closely with Quality on CAPAs, audit observations and remediation activities.
• Provide compliance oversight for facility improvements, remediation and capital projects.
• Ensure contractor activities meet appropriate safety, quality and compliance standards., Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.
• 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.
  At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community. We call this a 3D career, offering the opportunity to grow, make an impact and contribute to transforming patients' lives.
• Norgine: Transforming Healthcare, Backed by Over a Century of Expertise., At Norgine, you'll be part of an inclusive environment where different perspectives are valued. You'll have the opportunity to grow your career while making a meaningful impact on patients' lives. Our Drive, Dare and Develop values are central to how we work. We value people who take ownership and deliver results, respectfully challenge established thinking, seek better ways of working, collaborate effectively and help others realise their potential. We welcome applications from all backgrounds and are committed to building an inclusive workplace. Benefits may vary by location. Please liaise with the Norgine Talent Acquisition representative for further information. If you want a multi-dimensional 3D career in a leading healthcare organisation, join us.
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