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2 дня назад

QMS & Compliance Manager (Biotechnology)

Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
c1
Страна
Switzerland
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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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

hirify.global’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 hirify.global 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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