Description
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 Danaher’s (http://www.danaher.com/our-businesses) 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 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 (http://www.danaher.com/how-we-work/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 KPI’s 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:
+ Bachelor’s 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 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 (http://worklife.alight.com/ah-angular-afirst-web/#/web/danaher/cp/preauth-home) .
The annual salary range for this role is $215,000 – $250,000. 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 Company’s sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
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.
For more information, visit www.danaher.com .
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 (http://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf) .
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:1-202-419-7762 or applyassistance@danaher.com .
