Specialist, Quality Assurance Validation

Specialist, Quality Assurance Validation

Bothell, Washington, United States

Using living cells to treat – and sometimes even cure – cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However, these profound results have not yet been achieved in patients with solid tumors, representing approximately 90% of all cancers. And for patients with hematologic malignancies, there is a need for next-generation cell therapies that can deliver increased response rates and longer duration of response.

We are a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. Lyell's product candidates are enhanced with novel technology designed to generate T cells that resist exhaustion and have qualities of durable stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response. We were founded by cell therapy pioneers whose decades of research elevated the broader understanding of T-cell biology and its interaction with cancer.

In our quest to advance next-generation CAR T-cell therapies, we have built a fully integrated company capable of discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients. Our culture is based on Science, Respect, Collaboration, and Courage and reflects who we are, the environment we create, and our mission's urgency.

The Quality Assurance Specialist provides QA oversight for Facility, Equipment, Utility (FEU), and Computer System (CS) programs in a cell therapy manufacturing environment, with accountability for review, approval, escalation, and lifecycle compliance activities that support GMP readiness and sustained operational control.

This role serves as the Quality representative on cross-functional project teams and ensures Facility, Equipment, Utility, and Computer System activities are planned, executed, documented, and maintained in compliance with GMP requirements while supporting clinical and commercial operating timelines.

• Provide QA compliance oversight for Facility, Equipment, Utility, and Computer System qualification and validation projects.
• Review and approve validation plans, User Requirement Specifications (URS), protocols (IQ/OQ/PQ), and summary reports for equipment and systems.
• Maintain oversight of the qualified and validated state of Facility, Equipment, Utility, and computer systems through periodic review, requalification, deviation review, and change management.
• Create and manage qualification and validation project schedules.

• Support onboarding of new Facility, Equipment, and Utility assets by approving initial release requirements and defining quality expectations for lifecycle management.
• Provide QA oversight for the calibration and maintenance programs to ensure ongoing GMP compliance and operational readiness.
• Review and approve work plans including procedure, test points, tolerances, and acceptance criteria.
• Review and approve asset removal, return-to-service activities, and associated quality documentation.
• Review and approve on-demand work orders for unplanned events and repairs.

• Review and approve Standard Operating Procedures related to Facility, Equipment, Utility, and Computer System operation and maintenance.
• Review and approve change controls, deviations, and Corrective and Preventive Actions (CAPAs) related to Facility, Equipment, Utility, and Computer Systems.

• Understanding of requirements and expectations for compliant Facility, Equipment, and Utility programs including commissioning/qualification, calibration, and maintenance.
• Ability to work effectively both independently and cross-functionally.
• Fast learner, adaptable, and has the desire and ability to work in a fast-paced, start-up environment.
• Excellent communication, emotional intelligence and interpersonal skills.
• Familiar with quality management systems (e.g. deviations, CAPAs, change management).
• Curious and proactive mindset with a continuous improvement orientation.

• Bachelor's degree in life sciences or a related technical discipline with a minimum of 5 years of experience in a GMP biopharmaceutical manufacturing environment or equivalent combination of relevant education, training, and experience.

• Prior experience in a Quality Assurance oversight role for Facility, Equipment, and Utility qualification and management.
• Experience with computer system validation.
• Previous experience using Blue Mountain computerized maintenance management software.
• Experience with cell therapy and/or lentiviral manufacturing operations.
• Experience in commercial manufacturing and post-approval lifecycle…