Specialist, Quality Assurance Validation

About the role

The Quality Assurance Specialist provides QA oversight for Facility, Equipment, Utility (FEU), and Computer System (CS) programs in a cell therapy manufacturing environment. This role is accountable for review, approval, escalation, and lifecycle compliance activities that support GMP readiness and sustained operational control. The Specialist serves as the Quality representative on cross-functional project teams, ensuring 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.

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), 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.

Qualifications

• 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.

Skills

• 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.

Preferred 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 management.

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job:

• Stand and step over a gowning bench (12-24”) and aseptically don head-to-toe non-sterile and sterile gowns.

Schedule

While this position is primarily Monday – Friday, occasional off-shift work, weekend work, and holiday work may be required due to the nature of autologous cell therapies and the need to deliver life-saving treatments to patients as timely as possible.

Pay

The salary range for this position is $96,000 to $120,000 annually, with the opportunity to earn an annual bonus. The actual salary may vary based on qualifications and experience. Employees are also eligible to participate in Lyell’s Equity Incentive Plan.