Kent and South Wales
Site Quality Assurance / Regulatory Affairs Leader
Leadership role in a high achieving team.
Fast-paced, patient-centred work environment.
Opportunity to work within a broad and varied remit.
This is an opportunity to join a global biotechnology company within the Quality Team. This position will involve leadership of a team of Quality Professionals to ensure to ensure continuous quality and reliability of products. Great team structure in a fast-paced, customer focused business. What you’ll be doing
Undertaking the position of Management Representative in line with ISO13485:2016 certification requirements.
Deliver Quality Engineering support where needed.
Line management of direct reports, including development and coaching of; Quality Engineers, Senior Quality Engineers, Quality Graduate roles & Product Stewardship Specialists.
Participation in corporate audit programme ensuring adherence to all quality standards and regulations, as well as hosting external regulatory audits.
Implement quality and operational improvement work programmes, monitor and measure key metrics to ensure business improvements. Regulate good Quality Engineering Practice (gQEP) within operational areas to ensure continulous improvement.
Work with the Global Supplier Quality Leader to ensure all site processes are adhered to.
Coordinate with site development teams to ensure Quality compliance and liaise with Quality Engineers to manage produce recalls when necessary.
Take part in Material Review Board.
Collaborate with Operations to coordinate and prioritise production processes to ensure that safe and effective products are produced.
What they are looking for?
At least 3 years in Quality/Regulatory role with knowledge of ISO13485 and other international quality system standards.
Familiarity with leading and hosting Quality audits.
Science Degree as well as further Quality Qualifications – Certified Lead Auditor.
Lean (Six Sigma) desirable – analytical problem-solving skills with a risk base approach.
Great team management, organisation, and communication skills.
What you’ll get in return for your experience: A chance to join a global leader really making a difference in the work of biotechnology and diagnostics. Either located in Kent or South Wales – flexible and (part time) remote working available. Pension Scheme, generous annual leave, Life Assurance and Private Healthcare Scheme. What's next? For more information or to apply, apply directly to this advert to speak with Jazz Jones