Senior QA Lead, Supplier Quality — Remote

SAB; Sioux Falls (SD); Remote; USD 90,000 - 130,000; Full time

Job summary

SAB BIO is seeking a Sr. QA Specialist – Supplier Quality to lead third‑party qualification and ongoing quality oversight of suppliers, service providers, and CDMOs in a biotech setting.

The role requires 5+ years of QA experience in regulated manufacturing and strong collaboration with cross‑functional teams. The incumbent will manage audits, CAPA, change control, and document management, while mentoring junior staff and supporting regulatory inspections.

Qualifications

• BS/BA in life sciences; regulatory QA experience in biotech preferred.
• Minimum 5 years quality assurance in a regulated manufacturing environment (FDA/EMA/MHRA/HC) required.
• Experience qualifying and overseeing GMP suppliers and CDMOs with CAPA follow-up.
• Experience with GLP and GCP service providers preferred.
• Strong communication and presentation skills; proficient with MS Office.

Responsibilities

• Lead risk-based qualification and requalification of third parties through assessments, audits, and recommendations for approval.
• Oversee ongoing third-party quality oversight including performance monitoring, quality agreements, change notifications, and CAPA follow-up.
• Maintain third-party qualification records and approved status with timely reviews and risk escalation.
• Plan and conduct audits; prepare reports and follow up on corrective actions.
• Lead QA oversight of manufacturing and QC operations including batch record review, deviations, investigations, and change control.
• Present quality metrics and lead cross-functional projects to leadership.
• Drive quality systems ownership (change control, CAPA, document management) and process improvements.
• Author, review, and approve SOPs, batch records, and work instructions.
• Perform batch disposition activities and material approvals per specifications.
• Provide QA floor support during manufacturing; travel ~50% to supplier locations and CDMOs.

Education

BS/BA in life sciences

Tools

MS Office

eQMS

Job description

SAB BIO is seeking a Sr. QA Specialist – Supplier Quality to lead third‑party qualification and ongoing quality oversight of suppliers, service providers, and CDMOs in a biotech setting.

The role requires 5+ years of QA experience in regulated manufacturing and strong collaboration with cross‑functional teams. The incumbent will manage audits, CAPA, change control, and document management, while mentoring junior staff and supporting regulatory inspections.