Senior Quality Systems Lead – Life Sciences

Danaher Corporation; Fargo (ND); On-site; USD 90,000 - 120,000; Full time

Job summary

Aldevron, a Danaher operating company, seeks a Sr. Quality Compliance Associate – Quality Systems in Fargo, ND.

This on-site role leads complex quality system activities, oversight, and continuous improvement while partnering across functions to strengthen regulatory readiness. Responsibilities include reviewing deviations, CAPAs, and change controls; mentoring quality system owners; analyzing metrics; driving improvements; and coordinating with operations, technical, and quality teams on audits

Qualifications

• Bachelor’s degree in biology, microbiology, chemistry, or a life science field.
• 4+ years of QA experience in regulated pharmaceutical/biotech/medical device industries.
• Experience managing and reviewing quality system records (deviations, CAPAs, changes).
• Experience leading cross-functional investigations and risk assessments.

Responsibilities

• Lead review and approval of deviations, CAPAs, change controls to ensure compliance.
• Mentor and train quality system owners, reviewers, and cross-functional stakeholders.
• Analyze quality system performance metrics, identify adverse trends, and elevate risks to Quality Management.
• Lead continuous improvement initiatives to enhance site-wide compliance performance.
• Partner with operations, technical, and quality stakeholders on audits, client interactions, and regulatory inspections.

Skills

Quality Assurance

Quality systems

CAPA management

Change controls

Regulatory compliance

Data analysis

Education

Bachelor's degree in biology or life sciences

Job description

Aldevron, a Danaher operating company, seeks a Sr. Quality Compliance Associate – Quality Systems in Fargo, ND.

This on-site role leads complex quality system activities, oversight, and continuous improvement while partnering across functions to strengthen regulatory readiness. Responsibilities include reviewing deviations, CAPAs, and change controls; mentoring quality system owners; analyzing metrics; driving improvements; and coordinating with operations, technical, and quality teams on audits