Quality Director Cytiva Duncan
Duncan, SC - USA
Job Summary
Bring more to life.
Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnology
At Cytiva one of Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.
Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers 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 theDanaher Business System which makes everything possible.
As theQuality Director Duncan you will collaborate closely with cross-functional leadership and associates to ensure compliant execution monitoring and continuous improvement of the company QMS in line with certification requirements and customer expectations.
This position reports to the Sr Director QA - U&FM and leads both the Quality Control and Quality Assurance teams located in Duncan. This is an on-site role.
What you will do:
- Quality Leadership & Compliance: Serve as the Duncan sites 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 customer expectations. Drive continuous improvement with DBS mindset and in line with the global standards and customer expectations.
- Strategic Partnership & Advocacy: Collaborate with site and global leadership to advocate for site-specific needs drive customer-centric solutions support change management and change control initiatives
- Team Development & Performance: Build a high-performing quality department fostering a safe transparent and empowering environment that encourages skill development psychological safety and continuous improvement. Drive efficiency in site specific quality processes.
- Audits Reporting & Representation: Lead Quality Management Reviews for the site define and monitor KPIs in line with the global guidelines host audits and represent the site in executive discussions and global best practice initiatives.
Who you are:
- Hold a Bachelors 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 5 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 locations Worldwide as required.
Cytiva a Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits atDanaher Benefits Info.
Join our winning team today. Together well accelerate the real-life impact of tomorrows 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.
For more information visit.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race color national origin religion sex age marital status disability veteran status sexual orientation gender identity or other characteristics protected by law. 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.
The EEO posters are availablehere.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform crucial job functions and to receive other benefits and privileges of employment. Please contact us atto request accommodation.
Join our winning team today. Together well accelerate the real-life impact of tomorrows 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.
For more information visit .
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race color national origin religion sex age marital status disability veteran status sexual orientation gender identity or other characteristics protected by law.
The U.S. EEO posters are available here.
We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process to perform essential job functions and/or to receive other benefits and privileges of employment please contact:1- or .
Required Experience:
Director
About Company
WHO WE ARE We are a global science and technology innovator committed to helping customers solve complex challenges and improving quality of life around the world. These are the moments that make a difference. Performing a delicate operation on an unborn baby. Minimizing waste at ever ... View more