QMS Migration Lead: Regulatory & UAT

Tri-Valley Career Center; Hercules (CA); On-site; USD 55,104 - 59,236; Full time

Job summary

Bio-Rad is seeking a Quality Specialist II to manage the end-to-end migration of the Quality Management System from the legacy system to a new platform. You will map legacy documents, configure hierarchies, validate migrated content, and facilitate UAT with cross-functional teams.

This role emphasizes regulatory compliance (ISO 13485, FDA 21 CFR 820/210/211), training end-users, decommissioning legacy systems, and maintaining audit-ready documentation throughout the transition.

Qualifications

• Associate degree or equivalent in Biology, Chemistry, Engineering or related field.
• 3+ years in a regulated manufacturing industry.
• Familiarity with GMP and quality system standards (ISO 13485, FDA 21 CFR 820/210/211).
• Working knowledge of device/drug/biotech manufacturing processes.
• Proficiency in QMS databases, SAP, Veeva and Microsoft Office.
• Strong attention to detail and ability to manage multiple workstreams while collaborating cross-functionally.

Responsibilities

• Lead end-to-end migration of Quality Management System content.
• Coordinate cross-functional migration meetings across QA, Regulatory, and Operations.
• Conduct gap analyses against IVDR requirements and prioritize remediation.
• Support UAT activities and user adoption of Veeva Quality Docs workflows.
• Coordinate decommissioning and maintain audit readiness during transition.

Skills

Cross-functional collaboration

Project coordination

Attention to detail

Regulatory knowledge

Education

Associate degree or equivalent in Biology, Chemistry, Engineering or related field

Tools

QMS databases

SAP

Veeva

Microsoft Office

Job description

Bio-Rad is seeking a Quality Specialist II to manage the end-to-end migration of the Quality Management System from the legacy system to a new platform. You will map legacy documents, configure hierarchies, validate migrated content, and facilitate UAT with cross-functional teams.

This role emphasizes regulatory compliance (ISO 13485, FDA 21 CFR 820/210/211), training end-users, decommissioning legacy systems, and maintaining audit-ready documentation throughout the transition.