Responsible for providing quality assurance leadership and support to the Process Design & Validation Services (PDVS) business unit,. The PDVS team provides laboratory services to our BioPharma customers, as well as supporting internal R&D and manufacturing projects. This is an on-site position located at the Harbourgate site in Portsmouth, UK. What you'll do:

• Take responsibility for BU QMS documentation and processes to ensure compliance with the Corporate ISO9001 QMS, industry and regulatory requirements.
• Manage deviation and CAPA process. Ensure deviations are correctly captured, investigated, and trended, and that appropriate CAPA activities are initiated and completed within agreed timelines. Monitor effectiveness of CAPA.
• Host customer, third party and internal audits.
• Support the business in delivering against Quality KPIs.
• Support the Global PDVS Quality Leader on global Quality related initiatives.
Who you are


• Bachelor's degree in an applicable Science discipline, or equivalent experience in a regulated manufacturing industry (e.g Pharma, Biopharm, Life Science, Biotech).
• A minimum of 5 years working in Quality Assurance within Life Science or Biopharma manufacturing or laboratory environments.
• Hands-on experience with the requirements of applicable international quality systems (eg ISO9001, GMP).
• Excellent analytical, problem solving & root-cause analysis skills.
• Experience in hosting or supporting customer, regulatory or third-party audits.
It would be a plus if you also possess previous experience in:
• Continuous improvement methodologies & tools.
  
  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., 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.