Control & Quality Specialist

Location:

Folkestone

Job Type: Full-Time Temporary

Reporting to the European Head of Quality, you will be responsible for overseeing the European Change Control programme, ensuring quality processes remain compliant with GMP and regulatory requirements. You'll work collaboratively with teams across Europe and globally to deliver successful change initiatives and maintain an audit-ready quality management system.

• Lead and manage the European Change Control programme for temporary and permanent changes.
• Review change requests, assess business impact, and ensure compliance with GMP and applicable regulations.
• Coordinate stakeholders throughout the change control process.
• Monitor progress of change actions and ensure completion within agreed deadlines.
• Produce KPI reports and analyse change control performance.
• Identify opportunities to improve quality systems and change management processes.
• Deliver training, coaching and guidance on Change Control procedures.
• Maintain audit readiness and support internal and external audits.
• Support quality investigations, CAPA activities and continuous improvement initiatives.
• Assist in the development and maintenance of the Quality Management System (QMS).
• Ensure documentation, records and quality files are accurately maintained.

• A degree in Science, Engineering or a related discipline.
• At least three years' experience within a Quality or Technical function.
• Experience working within a regulated industry such as Pharmaceuticals, Medical Devices or FMCG.
• Strong knowledge of GMP and Quality Management Systems.
• Experience managing change control processes and implementing quality improvements.
• Knowledge of ISO 13485, ISO 22716, MDD and MDR.
• Experience supporting audits and regulatory inspections.
• Excellent communication and stakeholder management skills.
• Strong analytical skills with experience producing KPIs and trend analysis.
• A proactive approach with excellent attention to detail and a continuous improvement mindset.

You will be working 37 hours week Monday to Friday based between 2 sites and there may be the opportunity to work 1 day at home once full training is complete.

If you're an experienced Quality professional looking to take the next step in your career and make a real impact within a global organisation, we'd love to hear from you.

We are recruiting on behalf of a leading international manufacturer for a Change Control & Quality Specialist to join their European Quality team on a 6 month Temporary basis.

We are committed to fostering a diverse and inclusive environment in line with the Equality Act 2010. All qualified applicants will be considered regardless of age, disability, gender reassignment, marriage or civil partnership, pregnancy or maternity, race, religion or belief, sex, or sexual orientation.