Job Information
Danaher Corporation Principle Quality Specialist NC & CAPA in Little Chalfont, United Kingdom
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 Principal Quality Specialist NC and CAPA Manager for Cytiva is the global Nonconformance and CAPA process owner supporting the organization by assuring compliance to the regulations, and Cytiva’s QMS, with the monitoring of the process’s performance and implementing improvement actions as needed.
This position is part of the Cytiva QARA Governance department 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:
What you’ll do:
Own the global Non-conformance and CAPA processes and provide support and guidance to the entire Cytiva Quality Organization in accordance with Cytiva QMS, documented policies and procedures
Lead the Global CAPA Review Board (CRB) to assure awareness of CAPA status, timeliness, trends, effectiveness of actions and escalation if needed
Investigate, develop and propose effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA), through detailed analysis for deviations, non-conformances, and complaints
Monitor non-conformance and CAPA relevant KPIs and develop process improvement plans using a variety of Quality and Continuous Process Improvement tools, including but not limited to PSP (Problem-Solving Process), Lean Six Sigma, etc.
Create and manage best practices with participants at over 30 sites, including educating, training and coaching of Cytiva employees
The essential requirements of the job include:
Bachelor's Degree or a minimum of 10 years work experience in a regulated medical device or pharmaceutical industry. Desired: Master's Degree or PhD in Engineering or Technical Discipline
Proven track record of CAPA leader in either a site or a global function and in coaching teams and individuals in quality processes
Understanding or aptitude to understand GMP, Pharmaceutical, Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820, ISO 13485 and ISO 9001
Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies
Demonstrated expertise to effectively communicate within all levels of the organization around concepts of Corrective & Preventive Action (CAPA), problem solving and root cause analysis to support product quality improvements.
It would be a plus if you also possess previous experience in:
Experienced in performing internal and external audits
Exceptional analytical, problem solving and root-cause analysis skills
Excellent communication skills (written and oral)
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.