Senior Manager - QA

Be part of something altogether life-changing!

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. 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.

Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.

The Senior Manager QA for Cytiva is responsible for leading and developing a team of QA associates at the Umeå site and ensuring quality and regulatory compliance of the manufactured products.

This position is part of the Bioprocess Downstream HW and Resin Technologies within QA located in Umeå and will be an on-site role. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.

In this role, you will have the opportunity to:

• Accountable for ensuring quality and regulatory compliance of the Umeå manufactured products through the development, maintenance & monitoring of an ISO 9001 compliant Quality Management System.
• Lead and develops a team of quality associates responsible for maintaining the effectiveness of the Umeå QMS.
• Act as the senior QA authority for the Umeå manufacturing with regards to approvals associated with the QMS.
• Report on Quality System performance during Operational and Quality management reviews.
• Lead with a Danaher Business System (DBS) mindset influencing continuous improvement of QMS processes in line with KPI expectations.
• Collaborate closely with the Global QMS team and Quality Leaders on shared priorities including contributing to Global QMS process reviews.
• Acts a coach/mentor to Internal and Global functions that contribute to Umeå Quality & Compliance requirements – maintain close relationships with Product Regulatory function.

The essential requirements of the job include:

• Bachelor’s degree or higher, preferably in a Science or Engineering field.
• A minimum of 7 years working in Quality Assurance/Quality Engineering within Life Science, Medical Device or Biopharma manufacturing environments.
• Several years of supervisory/management experience is preferred.
• Comprehensive understanding of ISO 9001 requirements.
• Experienced in continuous improvement methodologies & tools.
• Experienced in leading external audits, including customer communications.
• Excellent organizational, presentation, meeting facilitation and technical writing skills.

It would be a plus if you also possess previous experience in:

• ISO 13485 requirements
• Biopharma GMP requirements

At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.

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.