Sr Quality Compliance Associate
Danaher•Fargo, ND
•Onsite
About The Position
The Sr. Quality Compliance Associate - Quality Systems leads complex quality system activities, provides advanced quality oversight, and drives continuous improvement across the site. Serving as a subject matter expert, this role partners across functions to assess quality risks, resolve complex compliance issues, improve quality system performance, and strengthen regulatory readiness. The position is part of the Quality Assurance team at Aldevron in Fargo, North Dakota, is on site, and reports to the Sr. Manager, Quality Systems.
Requirements
- Bachelor’s degree in biology, microbiology, chemistry, another life science field, or a related discipline.
- At least 4 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.
Nice To Haves
- Experience in biologics, cell and gene therapy, or pharmaceutical manufacturing environments.
- ASQ or RAPS certification.
Responsibilities
- 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, and serve as a subject matter expert on 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 to 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.
Benefits
- Health care program
- Paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Senior
