Description

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

Location

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

Requirements

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

Application

We encourage all individuals interested in this opportunity to apply via our career portal. 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.