Senior Quality Systems Lead - Life Sciences Compliance

Aldevron; Fargo (ND); Sur place; USD 95 000 - 130 000; Plein temps

Avantages offerts par ce poste

Benefits

Résumé du poste

Aldevron seeks a Sr. Quality Compliance Associate - Quality Systems to lead complex quality system activities and provide advanced oversight in Fargo, ND. You will assess quality risks, resolve compliance issues, and strengthen regulatory readiness as a subject matter expert within the Quality Assurance team.

This on-site role collaborates across functions. You will review deviations, CAPAs, change controls, and quality records while driving improvements, metrics analysis, and risk-based

Qualifications

• Bachelor’s degree in biology, microbiology, chemistry, other life science field, or related discipline is required.
• 4+ years of Quality Assurance experience in regulated pharma/biotech/medical device.
• Advanced experience managing and reviewing quality system records (deviations, CAPAs, change controls).
• Experience leading cross-functional investigations, risk assessments, or compliance initiatives.
• Experience analyzing quality metrics and driving continuous improvement.

Responsabilités

• Lead review and approval of complex deviations, CAPAs, change controls and other quality system records to ensure regulatory compliance.
• Mentor and train quality system owners, reviewers, and cross-functional stakeholders as a SME for quality system requirements.
• 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.
• Partner with operational, technical, and quality stakeholders on strategic projects, audits, client interactions, and regulatory inspections.

Connaissances

Quality Assurance

CAPA

Deviations

Change controls

Risk assessments

Cross-functional investigations

Regulatory compliance

Quality metrics

Formation

Bachelor’s degree in biology, microbiology, chemistry, life science or related discipline

Description du poste

Aldevron seeks a Sr. Quality Compliance Associate - Quality Systems to lead complex quality system activities and provide advanced oversight in Fargo, ND. You will assess quality risks, resolve compliance issues, and strengthen regulatory readiness as a subject matter expert within the Quality Assurance team.

This on-site role collaborates across functions. You will review deviations, CAPAs, change controls, and quality records while driving improvements, metrics analysis, and risk-based