Senior Quality Manager Validation And Project Support

Senior Quality Manager Validation And Project Support

At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world's most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.

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.

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.

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.