2 дня назад
QMS & Compliance Manager (Biotechnology)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
QMS & Compliance Manager (Biotechnology): Leading a unified quality management, internal audit, and complaints organization at a life sciences manufacturing site with an accent on CAPA, change control, deviation management, and regulatory readiness. Focus on driving systemic root-cause resolution, managing customer complaints and audits, and monitoring quality performance through daily visual management.
Location: On-site in Grens, Switzerland
Company
’s Cytiva operating company develops life sciences, diagnostics, and biotechnology solutions supporting biological research, vaccines, medicines, and cell and gene therapies.
What you will do
- Lead and unify the QMS, Internal Audit, and Complaints teams into a cohesive closed-loop quality organization.
- Drive continuous improvement across training, documentation, change control, CAPA, and deviation management.
- Oversee the end-to-end customer complaint process and ensure compliance with cycle-time targets.
- Manage the internal audit program and maintain readiness for regulatory, ISO, and customer inspections.
- Implement daily visual management and quality metrics tracking to monitor backlogs and team productivity.
- Partner with Operational QA to align the execution of key quality processes.
Requirements
- Bachelor’s or Master’s degree in Life Sciences, Engineering, Quality Management, or a related technical field.
- At least 7 years of Quality Assurance or Quality Management Systems experience in medical device, pharmaceutical, or biotechnology manufacturing.
- Demonstrated experience in direct people management or team leadership.
- Fluent written and spoken French and English required.
- Practical proficiency in root cause analysis methodologies and electronic Quality Management Systems.
- Ability to travel up to 10% for supplier audits or global quality network meetings.
Nice to have
- Lean, Six Sigma, or similar continuous improvement certification or practical experience, including the Business System.
- Experience managing quality processes under ISO 13485 and ISO 14971.
Culture & Benefits
- Work within a culture focused on belonging, continuous improvement, and tangible impact in human health.
- Access comprehensive benefit programs, including health care and paid time off.
- Eligibility for bonus or incentive pay.
- Collaborate with customers and quality professionals across a global life sciences network.
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