Quality Assurance Manager — Stem Cell GMP Leader (Onsite)

WiCell Research Institute, Inc.; Madison (WI); On-site; USD 80,000 - 120,000; Full time

Job summary

WiCell Research Institute, Inc. in Madison, WI is seeking a collaborative Quality Assurance Manager to uphold the quality standards for stem cell services and maintain WiCell's reputation for excellence.

The role involves leading QA activities for Stem Cell Bank and characterization services, managing the QA team, and coordinating audits, CAPAs, deviations, and document control in a fast-paced, deadline-driven environment.

Qualifications

• Minimum 4–5 years in GMP quality assurance or compliance within biotech/pharma industries.
• Bachelor's degree in a biological science or related field; ASQ certifications are a plus.
• Experience with quality systems, audits, CAPA and document control preferred.

Responsibilities

• Lead QA team and workload for stem cell bank release and quality reviews.
• Develop, update and maintain SOPs and regulatory documents.
• Manage internal and external audits and lead corrective actions.

Skills

GMP QA Experience

Compliance

Cell culture techniques

Quality systems

Auditing

Education

Bachelor's degree in biological sciences

Associate degree in related technical discipline

Tools

ASQ certifications (preferred)

Job description

WiCell Research Institute, Inc. in Madison, WI is seeking a collaborative Quality Assurance Manager to uphold the quality standards for stem cell services and maintain WiCell's reputation for excellence.

The role involves leading QA activities for Stem Cell Bank and characterization services, managing the QA team, and coordinating audits, CAPAs, deviations, and document control in a fast-paced, deadline-driven environment.