Impact QA Manager - Stem Cell Quality & Compliance

WiCell; Madison (WI); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Health benefits

Dental insurance

401(k) with company match

Generous PTO

Parental leave

Wellness programs

Job summary

WiCell, a leading non-profit stem cell services institute at UW–Madison, seeks a collaborative QA Manager to uphold quality and excellence. The role requires evaluating, investigating, solving problems, and responding to questions in a deadline-driven environment, with responsibility for Stem Cell Bank lot release and quality review across banking and characterization services.

You will lead a QA team, develop and maintain SOPs and quality systems, coordinate internal and external audits, manage

Qualifications

• A minimum of 4–5 years in GMP quality assurance or compliance within biotech/pharma.
• Bachelor's degree in a biological field or related technical discipline; or equivalent experience.
• Quality Assurance training (ASQ certifications) preferred but not required.

Responsibilities

• Implement, update and maintain quality systems (training, document control, safety, information management, equipment).
• Manage QA test tracking and product release for Stem Cell Bank products.
• Review and assign workload to QA Team (QC reports, batch records, vendor reports, documents, quality events).
• Develop and maintain SOPs and regulatory documents; ensure compliance.

Skills

QA management

GMP QA

Problem solving

Document control

Education

Bachelor's degree in biological sciences

Associate degree or related technical discipline

Tools

Quality Management Systems experience

Job description

WiCell, a leading non-profit stem cell services institute at UW–Madison, seeks a collaborative QA Manager to uphold quality and excellence. The role requires evaluating, investigating, solving problems, and responding to questions in a deadline-driven environment, with responsibility for Stem Cell Bank lot release and quality review across banking and characterization services.

You will lead a QA team, develop and maintain SOPs and quality systems, coordinate internal and external audits, manage