Sr Quality Compliance Associate

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences diagnostics and biotechnology

At Aldevron 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.

At Aldevron we deliver world-class CDMO services that accelerate the development of groundbreaking therapies. Our mission is to be the engine of innovation for genomic medicine pioneers. As a member of our team youll help bring life-changing innovations to lifeimpacting millions around the world. We bring together deep scientific expertise an unwavering commitment to quality and a collaborative spirit to drive progress. Whether youre launching your career or bringing years of experience we value the unique perspective you bring. Join us and become part of a mission-driven team advancing science and unlocking human potentialone discovery at a time.

Learn about the Danaher Business System which makes everything possible.

The Sr. Quality Compliance Associate - Quality Systems leads complex quality system activities provides advanced quality oversight and drives continuous improvement across the site. This role serves as a subject matter expert who partners across functions to assess quality risks resolve complex compliance issues improve quality system performance and strengthen regulatory readiness.

This position reports to the Sr. Manager Quality Systems and is part of the Quality Assurance team located in Fargo North Dakota. This role will be on site.

In this role you will have the opportunity to:

Lead the review and approval of highly complex deviations corrective and preventive actions (CAPAs) change controls and other quality system records to ensure compliance with applicable regulations and internal requirements.

Mentor and train quality system owners reviewers and cross-functional stakeholders while serving as a subject matter expert for quality system requirements and best practices.

Analyze quality system performance metrics identify adverse trends recommend corrective actions and escalate significant compliance risks to Quality Management.

Lead continuous improvement initiatives that enhance quality system effectiveness inspection readiness and site-wide compliance performance.

Partner with operational technical and quality stakeholders on strategic projects audits client interactions and regulatory inspections.

The essential requirements of the job include:

Bachelors degree in biology microbiology chemistry another life science field or a related discipline.

4 or more years of Quality Assurance experience in a regulated pharmaceutical biotechnology medical device or related industry.

Advanced experience managing and reviewing quality system records including deviations CAPAs and change controls.

Experience leading cross-functional investigations risk assessments or compliance initiatives.

Demonstrated experience analyzing quality metrics and driving continuous improvement activities.

It would be a plus if you also possess previous experience in:

Biologics cell and gene therapy or pharmaceutical manufacturing environments.

ASQ or RAPS certification.

Aldevron 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.

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.

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