Process Compliance Lead — Drive GMP Excellence

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

Job summary

Norgine is seeking a Process Compliance Lead to guide the Process Compliance team in Manufacturing Operations. You will use compliance data to identify risks and drive improvements, partnering with Manufacturing leadership to strengthen operational performance and sustainable compliance.

This role requires experience in quality, compliance or regulated operations, leading audits and CAPAs, and a collaborative approach across functions.

Qualifications

• Bachelor's degree or equivalent level.
• Strong experience within quality, compliance or regulated operations with the ability to advise others on complex situations.
• Experience leading or overseeing compliance programmes, audits, quality reviews, investigations, CAPAs and risk management activities.
• Strong understanding of GMP, regulatory expectations, Pharmaceutical Quality Systems and compliance controls.
• Experience using quality and operational data, KPIs and trend analysis to identify risk and drive continuous improvement.
• Experience supervising and directing people and resources to deliver defined outcomes.
• Strong stakeholder management, planning and communication skills.
• Experience with quality assurance methodologies, compliance systems, policies and procedures.
• Ability to manage complexity, establish priorities and drive sustainable process improvements.

Responsibilities

• Lead the Process Compliance programme, setting priorities, governance frameworks and improvement strategies across Manufacturing Operations.
• Establish compliance assurance processes using audits, self-inspections and quality reviews to identify risk and support inspection readiness.
• Provide governance and oversight of quality events, investigations, CAPAs and quality system actions, ensuring sustainable corrective actions are implemented.
• Identify, assess and manage compliance risks, escalating significant issues and ensuring effective mitigation.
• Lead compliance improvement initiatives that strengthen quality system effectiveness and operational performance.
• Develop and monitor KPIs, trends and compliance performance measures to support informed decision-making.
• Lead and develop the Process Compliance team, ensuring capability and priorities are aligned with compliance and business objectives.

Skills

Quality assurance

Regulatory compliance

GMP knowledge

Stakeholder management

People leadership

Leadership

Quality systems

Education

Bachelor's degree or equivalent level

Job description

Norgine is seeking a Process Compliance Lead to guide the Process Compliance team in Manufacturing Operations. You will use compliance data to identify risks and drive improvements, partnering with Manufacturing leadership to strengthen operational performance and sustainable compliance.

This role requires experience in quality, compliance or regulated operations, leading audits and CAPAs, and a collaborative approach across functions.