Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.
Learn about the Danaher Business System which makes everything possible.
The Senior Quality Manager Validation and Project Support is responsible for providing quality support and strategic guidance for validation activities and post-launch changes to equipment, systems, and launched IVD products. A central aspect of this role is to collaborate across global functions and sites, ensuring alignment and harmonization of quality approaches and validation strategies. This group offers opportunities for learning, project leadership, and career growth.
This position is part of the Quality Assurance Validation and will be located on site in Solna. At Cepheid, our vision is to be the leading provider of seamlessly connected diagnostic solutions.
In this role, you will have the opportunity to:
Manage direct reports in the QA validation team
Motivate and develop associates
Manage and prioritize the day-to-day work in the team
Plan and coordinate project resource allocation
Measure on-time delivery of team responsibilities
Lead and improve QA internal processes, recommend and implement improvements
Approve Quality System documents in document control system Agile
Support internal and external audits and act as SME
Collaborate closely with global QA and cross-functional teams to align validation strategies and quality processes
Drive harmonization of quality practices across international sites and contribute to global initiatives
The essential requirements of the job include:
BSc degree in Life Science
Multiple years of experience in Quality Assurance, in the medtech / pharma industry
Multiple years of experience in quality assurance roles, with leadership or managerial experience
ISO 13485:2016 knowledge
Excellent skills in written and verbal communication (English required – Swedish preferred)
It would be a plus if you also possess previous experience in:
Proven experience working in global or multi-site environments, with the ability to build strong cross-cultural relationships
Strong communication and influencing skills in international settings
Cepheid, 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. Check out our benefits at danaherbenefitsinfo.com.
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