Lyell Immunopharma · 15 hours ago
Manager, Quality Assurance
Bothell, Washington, United States
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expLyell Immunopharma is a clinical-stage company focused on advancing next-generation CAR T-cell therapies for patients with solid tumors and hematologic malignancies. The Manager of Quality Assurance will lead day-to-day QA operations, ensuring compliance with GMP regulations, performing batch record reviews, and supporting continuous improvement initiatives within the manufacturing facility.
BiotechnologyHealth CareMedicalPharmaceutical
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
Qualification
Required
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
Preferred
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
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)
Benefits
Subsidized medical, dental and vision plans from your first day of employment
FSA
Company provided Life and AD&D Insurance
STD and LTD Insurance
ESPP
A 401(k) Plan with Company match
Mass transit commuter benefits
Cell phone reimbursement
A range of supplemental benefits that you may choose to elect
Flex Time off
Sick leave
8 observed holidays
A floating holiday
Winter office shutdown
Company
Lyell Immunopharma
Lyell Immunopharma is an operator of a biotechnology company that develops cellular therapies to cure cancer.
201-500 employees
H1B Sponsorship
Lyell Immunopharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (2)
2023 (2)
2022 (5)
2021 (2)
2020 (3)
Funding
Current Stage
Public CompanyTotal Funding
$543M2025-07-25Post Ipo Equity· $50M
2021-06-16IPO
2020-03-12Series C· $493M
Leadership Team
Lynn Seely
President & Chief Executive Officer
Gary Lee
Chief Scientific Officer
Recent News
2025-12-25
2025-12-19
2025-12-09
Company data provided by crunchbase