Process Compliance Lead

Norgine B.V.; Cefn Hengoed; On-site; GBP 70,000 - 95,000; Full time

Job summary

Norgine is seeking a Process Compliance Lead to lead and develop the Process Compliance team, using compliance data to identify risks and drive improvements across Manufacturing Operations.

You will partner with Manufacturing leadership to ensure effective governance, manage CAPAs and quality reviews, develop KPIs, and build a culture of continuous improvement in a collaborative, inclusive environment.

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 compliance

GMP knowledge

Regulated ops

Data analysis

Stakeholder mgmt

Team leadership

Education

Bachelor's degree

Job description

We have an exciting opportunity for a Process Compliance Lead to join Norgine. You will lead and develop the Process Compliance team, using compliance and performance data to identify risks and improvement opportunities while working cross-functionally to strengthen operational performance and sustainable compliance. As a key compliance partner to Manufacturing leadership, you will help ensure compliance risks are identified, escalated and effectively managed, while promoting accountability and continuous improvement across Operations.

• 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.

At Norgine, you'll be part of an inclusive environment where diverse perspectives are valued. You'll have the opportunity to grow your career while making a meaningful impact on patients' lives.

Ways of Thinking & Working to Support Your Growth

• Curious, reflective and open to different perspectives
• Collaborative across teams, functions and geographies
• Comfortable working independently and asking questions when needed
• 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.

The role requires a collaborative and accountable approach, with the confidence to address difficult issues, communicate effectively and build trust across functions. The role also aligns strongly with Norgine's Drive, Dare and Develop core competencies, including delivering results, taking action, demonstrating courage, collaborating, valuing different perspectives and communicating effectively.

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 it the 3D career at Norgine, offering a fully-rounded experience with opportunities to make a difference, build your career and be part of a supportive community.

Norgine: Transforming Healthcare, Backed by Over a Century of Expertise.