Specialist, Quality Assurance Validation

About the role

Lyell is a clinical‑stage company advancing next‑generation CAR T‑cell therapies for solid tumors and hematologic malignancies. The Quality Assurance Specialist provides QA oversight for Facility, Equipment, Utility (FEU), and Computer System (CS) programs in a cell therapy manufacturing environment, ensuring GMP readiness and sustained operational control while supporting clinical and commercial timelines.

Key Responsibilities

• Provide QA compliance oversight for Facility, Equipment, Utility, and Computer System qualification and validation projects.
• Review and approve validation plans, User Requirement Specifications (URS), IQ/OQ/PQ protocols, and summary reports.
• Maintain the qualified and validated state of assets through periodic review, re‑qualification, 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.
• Oversee calibration and maintenance programs to ensure ongoing GMP compliance and operational readiness.
• Review and approve work plans, 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) for Facility, Equipment, Utility, and Computer Systems.

Knowledge, Skills, and Abilities

• Understanding of requirements 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 comfortable in a fast‑paced, start‑up environment.
• Excellent communication, emotional intelligence, and interpersonal skills.
• Familiarity with quality management systems (e.g., deviations, CAPAs, change management).
• Curious, proactive mindset with a continuous‑improvement orientation.

Required Education and Experience

• Bachelor’s degree in life sciences or a related technical discipline.
• Minimum of 5 years of experience in a GMP biopharmaceutical manufacturing environment, or an equivalent combination of education, training, and experience.

Preferred Experience

• Prior QA oversight role for Facility, Equipment, and Utility qualification and management.
• Experience with computer system validation.
• Experience using Blue Mountain computerized maintenance management software.
• Background in cell therapy and/or lentiviral manufacturing operations.
• Experience in commercial manufacturing and post‑approval lifecycle management.

Physical Requirements

• Ability to stand and step over a gowning bench (12–24 in) and aseptically don head‑to‑toe non‑sterile and sterile gowns.

Schedule

Primarily Monday – Friday; occasional off‑shift, weekend, and holiday work may be required to support autologous cell therapy production and timely patient treatment.

Pay

Salary range: $96,000 – $130,000 annually, with the opportunity to earn an annual bonus. Employees are also eligible to participate in Lyell’s Equity Incentive Plan.

Benefits

Lyell offers an inclusive, diverse culture and participation in the Equity Incentive Plan, reflecting the company’s commitment to building high‑performing, collaborative teams.