Director Site Quality
Danaher Corporation, Combe Martin, Devon
- Full time
- Permanent
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Danaher Corporation, Combe Martin, Devon
- Onsite working
- Full time
- Permanent
Posted today, 6 Feb
Job ref: 15457eb0b8404aacbd47464e36e6ee1b
Full Job Description
As the Director Site Quality you will collaborate closely with cross functional leadership and associates to ensure compliant execution, monitoring, and continuous improvement of the implemented QMS in line with certification requirements and customer expectations. This position reports to the Sr Director QA Bioprocess Filtration and leads both the Quality Control and Quality Assurance teams located in Ilfracombe . This is an on-site role. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery. What you will do:
- Quality Leadership & Compliance: Serve as the Ilfracombe site's Quality Management Representative, leading QA/QC functions, ensuring regulatory compliance, and aligning with organizational quality goals.
- Quality Management System (QMS): Implement, maintain, and optimize the Cytiva QMS, ensuring procedures, work instructions, and IT systems support site operations and lead with DBS mindset to drive continuous improvement.
- Strategic Partnership & Advocacy: Collaborate with site and global leadership to address process changes, advocate for site-specific needs, and drive customer-centric solutions during change management initiatives.
- Team Development & Performance: Build a high-performing quality department, fostering a safe, empowering environment that encourages skill development, psychological safety, and continuous improvement.
- Audits, Reporting, & Representation: Lead Quality Management Reviews, define and monitor KPIs, host audits, and represent the site in executive discussions and global best practice initiatives.
Hold a Bachelor's degree, preferably in Science, Business, or Engineering. - Have at least 7 years of experience in Quality Assurance, Quality Engineering, or Manufacturing Operations within Life Sciences, Biotechnology, Medical Device, Biopharma, or other FDA/EPA-regulated manufacturing environments.
- Possess several years of leadership experience, with senior leadership roles in QA, Operations, or Quality Engineering preferred.
- Regulatory and Quality Expertise: Strong knowledge of ISO standards, FDA regulations, cGMPs, CFR requirements, and quality management practices, including operational controls, CAPA, complaints, audits, and risk management.
- Analytical and Process Optimization: Proficiency in quality statistical methods, Lean Manufacturing principles, Six Sigma methodologies, and Root Cause Analysis tools to drive data-driven decisions and resource optimization.
- Leadership and Communication: Proven ability to lead, coach, and mentor teams; manage performance; plan succession; and effectively communicate at all organizational levels, both written and verbal.
- Strategic and Operational Acumen: Skilled in managing budgets, assessing opportunity costs, and fostering innovative problem-solving, while maintaining exceptional organizational and time management capabilities. Travel, Motor Vehicle Record & Physical/Environment Requirements:
- Ability to travel 10% of the time to other Cytiva manufacturing locations in Europe and Worldwide, as required.
Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cytiva, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. 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 who care for each other, our customers, and their patients. Take your next step to an altogether life-changing career. Learn about the Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) , which makes everything possible., Cytiva, 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. Check out our benefits at Danaher Benefits Info (https://leplb1040.upoint.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home) . 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.
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Danaher Corporation
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