Senior Director Quality Assurance Filtration
Marlborough, NH - 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 that 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 which makes everything possible.
The Senior Director Quality Assurance Filtration will partner globally with internal and external stakeholders to manage a world-class Quality Assurance program for the to enhance growth. This role will report into the VP Quality Assurance for Cytiva and will further support the Filtration VP & GM and will be part of both leadership teams. The work arrangement for this role will be onsite.
What you will do:
Partner with the Global QARA leaders and the Filtration leadership to drive functional initiatives supportive of the business priorities enabling business strategy and growth.
Accountable for setting and monitoring Quality KPIs to include reporting on performance/trend insights through business reviews. Further drive KPI implementation across all sites operations and functions.
Manage the quality system which provides guidance tracking and metrics of compliance. Further develop and lead audit/inspection readiness activities to meet compliance and regulatory requirements.
Lead through DBS driving functional efficiencies and improvement development of the QMS QA processes and QA support function/organization.
Lead the global team across all Filtration QARA functions and sites. Assume all functional responsibilities including people development performance supplier quality and financial responsibilities.
Who you are:
Bachelors degree and minimum 15 years work experience in a Quality or Regulatory Assurance related field including medical devices.
Comprehensive knowledge of Quality Systems which ensure that products processes and services consistently meet or exceed the desired quality standards including compliance to ISO 9001 ISO 10993 FDA 21 CFR Part 820 and ISO 13485 MDR MD-SAP and other relevant medical country specific requirements.
Working knowledge of manufacturing processes product assembly materials and properties.
Demonstrated understanding of root cause analysis corrective and preventive action (CAPA) change control verification and validation methodologies manufacturing/production process control methodologies risk management and continuous improvement in a medical device environment.
Demonstrated knowledge of Quality Management System tools and ability to effectively communicate within all levels of the organization.
10 years of people leader experience preferably globally.
Travel Motor Vehicle Record & Physical/Environment Requirements:
Ability to travel 30% - 50% global travel per business needs
It would be a plus if you also possess previous experience in:
Continuous improvement processes and operational excellence
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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 at Danaher Benefits Info.
The annual salary range for this role is $215000 - $250000. This is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. This range may be modified in the future.
This job is also eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole discretion unless and until paid and may be modified at the Companys sole discretion consistent with the law.
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:
Exec
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