Change Control & Quality Specialist

About the role

We are seeking an experienced Change Control & Quality Specialist to join the European Quality team of a leading international manufacturer on a six‑month contract. Based in Folkestone, you will oversee the European Change Control programme, ensuring all temporary and permanent changes comply with GMP and relevant regulations while supporting continuous improvement.

Key responsibilities

• Lead and manage the European Change Control programme for both temporary and permanent changes.
• Review change requests, assess business impact and verify compliance with GMP, ISO standards and regulatory requirements.
• Coordinate stakeholders throughout the change control lifecycle and monitor progress against agreed deadlines.
• Produce KPI reports, analyse change control performance and identify opportunities for improvement.
• Deliver training, coaching and guidance on Change Control procedures to internal teams.
• Maintain audit readiness, support internal and external audits, and assist with quality investigations and CAPA activities.
• Contribute to the development and maintenance of the Quality Management System and ensure accurate documentation.

Required profile

• Degree in Science, Engineering or a related discipline.
• Minimum three years’ experience in a Quality or Technical role within a regulated industry (pharmaceuticals, medical devices or FMCG).
• Strong knowledge of GMP and Quality Management Systems.
• Experience managing change control processes and driving quality improvements.
• Familiarity with ISO 13485, ISO 22716, MDD and MDR standards.
• Proven ability to support audits and regulatory inspections.
• Excellent communication, stakeholder management and analytical skills.

Required skills

• Good Manufacturing Practice (GMP)
• ISO 13485
• ISO 22716
• MDD (Medical Device Directive)
• MDR (Medical Device Regulation)
• Quality Management Systems (QMS)