Senior Site Quality Manager (f/m/d) at Danaher - Canada

Grens, Vaud, Switzerland -

Full Time

Start Date

Immediate

Expiry Date

14 Mar, 26

Salary

0.0

Posted On

14 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Quality Engineering, Regulatory Compliance, Analytical Skills, Problem Solving, Root-Cause Analysis, Organizational Skills, Presentation Skills, Technical Writing, Project Management, Cross-Functional Collaboration, Fluency in French, Fluency in English, Medical Device Manufacturing, GMP Experience, Training Delivery

Industry

Medical Equipment Manufacturing

Description

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. This position will be on-site at our Signy Facility (Grens, Vaud) in Switzerland. What you’ll do: Lead the site QA team and be part of the extended site leadership team working with cross functional groups at and above site. Accountable for ensuring full quality and regulatory compliance of the Signy facility and associated franchises, while driving process effectiveness and efficiency at the site. Accountable to provide site Quality System Overview training, CGMP orientation and Annual Refresher training, Good Documentation Practices training, as well as Deviation Writing training. Accountable for hosting customers compliance and site qualification audits. Who you are: Bachelor's Degree is required, preferably in microbiology, cell biology, molecular biology, biochemical or chemical engineering, or related field such as Quality Management. A minimum of 10 years working in the pharmaceutical or medical device industry. Quality Assurance/Quality Engineering experience in the medical device industry or Pharma GMP experience in quality assurance. A minimum of 3 years supervisory/management experience is preferred. Understanding of medical device manufacturing QMS requirements and regulatory requirements including but not limited to ISO 13485, ISO 9001, ISO 14971, Medical Device Regulation (MDR) 2017/745, FDA 21 CFR 820, 210 & 211, and application to the manufacture of medical device. Exceptional analytical, problem solving & root-cause analysis skills. Excellent organizational, presentation, meeting facilitation and technical writing skills. Experienced in managing project teams and working cross-functionally, at global level. Fluent in French and English language. It would be a plus if you also possess previous experience in: Quality and/or operational roles across Life Sciences regulated industries. First-hand experience in preparation, execution and follow-up of regulatory audits. #LI-MK2 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. Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world’s most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow. The Danaher ecosystem is made up of more than 15 businesses united by a shared commitment to innovate for tangible impact. Please read our Applicant Data Privacy Notice carefully here.

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Responsibilities

Lead the site QA team and ensure full quality and regulatory compliance of the Signy facility. Provide training on quality systems and host customer compliance audits.