Quality Assurance Manager

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, a leading non-profit stem cell services institute and supporting organization of UW-Madison, seeks a collaborative, detail-oriented Quality Assurance (QA) Manager to join our team and help uphold the reputation of quality and excellence for which we are known. This position offers the opportunity to make a significant contribution to the advancement of stem cell research within a supportive environment.

The Role

The QA Manager will embody WiCell’s culture of quality and values and align daily actions with departmental goals. The QA Manager requires the ability to evaluate, investigate, solve problems, and respond to quality-related questions and requests in a deadline-controlled environment. This position is responsible for performing and assigning workload to the QA team for activities related to Stem Cell Bank lot release and quality review related to both banking and characterization services and maintaining quality systems in accordance with the applicable quality standards. The QA Manager plays a pivotal role in upholding the quality and integrity of WiCell's Stem Cell Bank (non-cGMP) and characterization services (cGMP and non-cGMP).

Key responsibilities include:

• Implement, update and support and maintain various aspects of quality systems: including training document control, safety, information management and equipment
• Manage QA Test tracking and product release: of WiCell Stem Cell Bank products which adhere to the highest quality standards, maintaining WiCell's reputation for quality
• Review and assign workload to QA Team: including QC reports, characterization reports, batch records, vendor reports, version-controlled documents and quality events
• SOP development and maintenance: Approve, draft, revise and implement standard operating procedures (SOPs), and other regulatory requirements
• Manage internal and external audits: maintain audit schedule and forms and act as lead auditor during audits
• Managing quality events: such as investigation (CAPA) and deviations, including identifying preventative actions and corrective actions

What You Bring to WiCell

• Experience: A minimum of 4-5 years in GMP quality assurance or compliance within the pharmaceutical or biotech industries. Experience in sterile culture techniques or culturing mammalian cells is preferred, but not required
• Education: Bachelor's degree in a biological scientific field, an associate degree in a related technical discipline, or equivalent experience
• Training: Quality Assurance training (i.e., ASQ certifications) preferred, but not required

Why WiCell?

• Scientific impact: Contribute to the advancement of cutting-edge stem cell research and positively influence the field
• Employee-focused culture: We value work-life flexibility and offer a supportive environment
• Excellent benefits: Competitive compensation, comprehensive benefits package (health, dental, 401(k) with company match, generous PTO, parental leave, wellness programs, and more)

Location:

This is a full-time, onsite position at 504 S. Rosa Road in Research Park, Madison.

Applicants must be authorized to work for any employer in the United States. We are unable to sponsor or take over sponsorship of an employment visa.

Our recruitment process for this position will include resume review, phone interview, virtual interview, and an on-site interview for candidates selected to move forward.

WiCell promotes and supports an inclusive environment and encourages all individuals to apply if you believe you can learn and perform the required responsibility of this position. We are committed to working with and providing reasonable accommodation to individuals with disabilities throughout the employment process. To request accommodation, please contact Human Resources.