6 дней назад
Senior Manager, Quality and Site QMR (Medical Devices)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Manager, Quality and Site QMR (Medical Devices): Leading the Quality function at a Liverpool manufacturing site, ensuring products, processes, and quality systems meet international regulatory and business requirements with an accent on GMP, ISO 13485, validation, and regulatory compliance. Focus on managing the site Quality team, maintaining licences and regulatory commitments, supporting MHRA and FDA audits, and driving continuous improvement in a regulated manufacturing environment.
Location: Liverpool, Merseyside, United Kingdom; onsite at the Liverpool manufacturing site
Company
develops vital organ therapies, digital solutions, and advanced services, with a long-standing focus on kidney care and dialysis.
What you will do
- Lead and develop the Liverpool Quality team through relevant line managers.
- Act as Site Quality Management Representative and represent Quality on the Site Leadership Team.
- Ensure products manufactured, packaged, and supplied from the site comply with international quality regulations.
- Oversee quality systems, procedures, qualification, and validation activities.
- Maintain GMP, ISO 13485, and regulatory performance across the site.
- Escalate significant quality matters and implement improvements supporting compliance and site performance.
Requirements
- Scientific or engineering degree.
- At least eight years of experience in Quality Assurance, Quality Control, Regulatory Affairs, or a related area.
- Quality management experience in pharmaceutical or medical device manufacturing.
- Experience with active pharmaceutical ingredient manufacturing and MHRA or FDA audits.
- Comprehensive knowledge of cGMP and relevant EU, FDA, and PIC/S requirements.
- Strong people leadership, communication, problem-solving, and project-management skills.
Culture & Benefits
- Key site leadership role focused on product quality, regulatory compliance, and Quality team development.
- Collaboration with Manufacturing and other functions to support site objectives.
- Competitive salary and annual bonus.
- Pension contribution, car allowance, and 25 days of annual leave.
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