QMS & Compliance Manager (f/d/m)

Cytiva

Grens

Vor Ort

CHF 120.000 - 180.000

Vollzeit

14 Tage+

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Benefits dieser Stelle

Bonus eligible
Comprehensive benefits

Zusammenfassung

Cytiva, a Danaher operating company, is seeking a QMS & Compliance Manager to lead the unified Quality Management System, Internal Audit, and Complaints teams at the Signy site in Grens, Switzerland. This on-site role reports to the Site Quality Director and drives systemic root-cause problem solving across quality processes.

You will oversee training, change control, CAPA, deviation management, and interface with Operational QA to ensure aligned execution. Travel is up to 10%.

Qualifikationen

  • Bachelor's or Master's degree in Life Sciences, Engineering, Quality Management, or related technical field.
  • At least 7 years experience in Quality Assurance or Quality Management Systems within the medical device, pharmaceutical, or biotechnology manufacturing industries.
  • Direct people-management or team-leadership experience.
  • Fluent in French and English language (written and spoken).
  • Proficient in Root Cause Analysis and electronic Quality Management Systems (eQMS).

Aufgaben

  • Lead, mentor, and unify the QMS, Internal Audit, and Complaints personnel into a single, cohesive team executing a closed-loop quality system.
  • Drive continuous improvement in Training, Documentation, Change Control, CAPA and deviation management, transitioning the site toward robust, systemic root-cause resolution.
  • Oversee the end-to-end customer complaint process, ensuring strict adherence to cycle-time targets and therapeutic expectations.
  • Manage the internal audit program and maintain site readiness for external regulatory, ISO, and customer inspections.
  • Implement and sustain daily visual management (+QDIP) to monitor quality metrics, track operational backlogs, and drive team productivity.
  • Act as interface with the Operational QA to ensure consistent execution and alignment regarding the execution of key quality processes.

Kenntnisse

French language
English language
Root cause analysis
eQMS

Ausbildung

Bachelor's or Master's degree in Life Sciences, Engineering, Quality Management, or related technical field

Tools

eQMS

Jobbeschreibung

Bring more to life.Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life.

Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.

At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career.

Learn about the Danaher Business System which makes everything possible.

The QMS & Compliance Manager is responsible for leading the unified Quality Management System, Internal Audit, and Complaints teams, driving systemic root-cause problem solving and operational excellence across the site's quality processes.

This position reports to the Site Quality Director and is part of the Quality Assurance team located at our Signy facility in Grens, Switzerland. It will be an on-site role.

What You Will Do
  • Lead, mentor, and unify the QMS, Internal Audit, and Complaints personnel into a single, cohesive team executing a closed-loop quality system.
  • Drive continuous improvement in Training, Documentation, Change Control, CAPA and deviation management, transitioning the site toward robust, systemic root-cause resolution.
  • Oversee the end-to-end customer complaint process, ensuring strict adherence to cycle-time targets and therapeutic expectations.
  • Manage the internal audit program and maintain site readiness for external regulatory, ISO, and customer inspections.
  • Implement and sustain daily visual management (+QDIP) to monitor quality metrics, track operational backlogs, and drive team productivity.
  • Act as interface with the Operational QA to ensure consistent execution and alignment regarding the execution of key quality processes.
Who You Are
  • Bachelor's or Master's degree in Life Sciences, Engineering, Quality Management, or a related technical field.
  • At least 7 years experience in Quality Assurance or Quality Management Systems within the medical device, pharmaceutical, or biotechnology manufacturing industries.
  • Demonstrated experience in a direct people-management or team-leadership role.
  • Fluent in both French and English language (written and spoken).
  • Practical proficiency in utilizing Root Cause Analysis methodologies and electronic Quality Management Systems (eQMS).
Travel, Motor Vehicle Record & Physical/Environment Requirements
  • Ability to travel up to 10% (occasional travel for supplier audits or global quality network meetings).
It would be a plus if you also possess previous experience in:
  • Formal certification or practical experience in Lean, Six Sigma, or similar continuous improvement frameworks (e.g., Danaher Business System).
  • Direct experience managing quality processes under ISO 13485 and ISO 14971 standards.

Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job.

This job is also eligible for bonus/incentive pay.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

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