Full Job Description
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:
• Bachelor's 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 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.
