Senior Manager Site Quality

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 Sr Manager Site Quality Ilfracombe  for Cytiva is responsible for execution, monitoring, and continuous improvement of the implemented QMS in line with certification requirements and customer expectations.

This position is part of the global QARA Filtration organization, located in Ilfracombe and will be  on-site,.At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.

In this role, you will have the opportunity to:

• Represent the Ilfracombe site as the Quality Management Representative and lead management reviews
• Responsible for the leadership & development of the QA site function.
• Responsible for implementing the Cytiva QMS
• Ensure QMS procedures, work instructions, and IT System effectively support the Ilfracombe site organization - Collaborate with Global QMS Subject Matter Experts (SME) as required.
• Support the Global QMS team on Global process and procedure changes and represent the needs of the site during change management and continuous improvement discussions.
• Accountable for setting & monitoring Quality KPI’s including, reporting on performance/ trend insights within business reviews.
• Ensure effective communication style with stakeholders and establish cross functional operating mechanisms, where appropriate to ensure Quality goals are met.

The essential requirements of the job include:

• Minimum, Bachelor's degree, preferably in a Science or Engineering discipline
• A minimum of 5 years working in Quality Assurance/Quality Engineering  or Product Engineering  -within Life Science, Medical Device or Biopharma manufacturing environments
• 2-4 years of supervisory experience
• Knowledge of ISO, FDA, cGMP’s, and CFR requirements
• Experience with Root Cause Analysis Tools, Lean Manufacturing, and Six Sigma.
• Knowledge of quality statistical methods and tools
• Experience supporting validation and technology transfer activities.

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.