Manager, Quality Assurance

Lyell Immunopharma • Bothell, WA

24d

About The Position

The incumbent is responsible for leading and overseeing day-to-day Quality Assurance (QA) operations for the LyFE manufacturing facility, including leadership for the QA team. This role has primary responsibility for drug product batch disposition and collaborates closely with the LyFE GMP Manufacturing Center teams to support technology transfers and continuous improvements of GMP processes. The incumbent will perform and oversee routine Quality Assurance activities, including but not limited to batch record review and disposition, raw material disposition, and approval of records (e.g. deviation, CAPAs, change controls, and nonconformances).  This role also supports broader Quality Operations activities to ensure compliance, operational excellence, and product quality.

Requirements

• Experience in cGMP clinical manufacturing required.
• Experience with electronic quality management systems (e.g. deviations, CAPAs, change management) required.
• Demonstrated ability to lead, mentor, and develop team members, including setting performance expectations, providing coaching, and fostering professional growth.
• Proven capability to oversee QA operations and workflows, ensuring timely execution, compliance, and alignment with organizational priorities.
• Ability to work effectively (both independently and cross-functionally) with Manufacturing, MSAT, Regulatory, Patient Operations, Supply Chain, and external partners to set goals, develop sound project plans, monitor progress, and report results.
• Excellent communication, emotional intelligence and interpersonal skills.
• Curious and proactive mindset with a continuous improvement orientation; actively seeks to understand processes, identify risks, and implement sustainable quality solutions.
• Fast learner, adaptable, and has the desire and ability to work in a fast-paced, start-up environment.
• Excellent analytical skills and scientific/technical expertise.
• BS with a minimum of 10 years’ experience in biochemistry, chemical engineering, bioengineering, or related scientific field; or
• MS with a minimum of 7 years’ experience in biochemistry, chemical engineering, bioengineering, or related scientific field

Nice To Haves

• Minimum of 10 years of experience in cGMP biopharmaceutical manufacturing operations including 2 years in cell therapy and/or lentiviral manufacturing operations.
• Minimum of 3 years of experience managing people in technical GMP roles.
• Minimum of 3 years in GMP Quality Assurance and/or extensive experience with quality management systems (e.g. Deviations, CAPAs, Change Controls).

Responsibilities

• Responsible for supporting Quality oversight of GMP operations at the manufacturing facility and ensuring adherence to applicable GMP regulations and Lyell policies and procedures.
• Responsible for ensuring drug products are promptly dispositioned at the appropriate stages (Release for Infusion, Release for shipment etc.) to ensure on time product delivery to patient.
• Perform review and approval of executed electronic batch records, including the identification and investigation of deviations with cross functional personnel.
• Provide on the floor quality support for applicable manufacturing operations in the cleanroom facilities during operations (potentially including non-routine working hours and holidays).
• Perform routine QA activities including incoming patient apheresis receipt, drug product packaging operations, drug product disposition and audit support.
• Perform routine raw material review and disposition and approval of raw material.
• Provide quality oversight as well as review and approval of QMS records (Deviations, Change Controls, Excursions, CAPAs, Non-Conformances, Complaints).
• Maintain Quality Key Performance Indicators (KPIs) to achieve business goals.
• Represent Quality Assurance on project specific teams for clinical products.
• Collaborate with other leaders at the site to assist in the continuous improvement, lifecycle management of GMP procedures and BLA/PLI readiness activities.

Benefits

• Our Employee Benefits program is extensive and includes subsidized medical, dental and vision plans from your first day of employment, FSA, Company provided Life and AD&D Insurance as well as STD and LTD Insurance, ESPP, a 401(k) Plan with Company match, mass transit commuter benefits, cell phone reimbursement and a range of supplemental benefits that you may choose to elect.
• Our paid time-off benefits currently include Flex Time off, sick leave, 8 observed holidays as well as a floating holiday.
• We also have a winter office shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 251-500 employees