Danaher Corporation Senior Site Quality Manager in Grens, Switzerland
Be part of something altogether life-changing!
Working at Cytiva in the Life Sciences industry 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. With associates across 40 countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.
Cytiva is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
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 provides 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 and at global level
It would be a plus if you also possess previous experience in:
Quality and or operational roles in the Life Science regulator industries.
First hand experience in preparation, execution and follow up of regulatory audits.
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you’ve ever wondered what’s within you, there’s no better time to find out.