Lyell Immunopharma · 2 months ago
Director, Clinical Quality Assurance
South San Francisco, CA
Full-time
Hybrid
Director/Executive
$200K/yr - $245K/yr
10+ years expLyell Immunopharma is a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. The Director of Clinical Quality Assurance will lead and manage clinical quality systems, ensuring compliance with Good Clinical Practice across all trial activities and establishing robust quality programs.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Develop and implement a clinical quality assurance strategy aligned with company goals and regulatory expectations
Serve as the subject matter expert (SME) in GCP and clinical compliance regulations and guidelines (e.g., FDA, EMA, ICH)
Provide quality oversight and guidance to cross-functional clinical teams and executive leadership
Design, manage, and conduct internal and external GCP audits (e.g., site audits, vendor audits, TMF audits)
Oversee audit findings, CAPA development, and follow-up to ensure timely resolution
Collaborate with CROs, vendors, and clinical sites to ensure quality expectations are met
Lead clinical inspection readiness activities for regulatory agency inspections
Serve as the CQA representative during inspections, ensuring timely and accurate responses
Establish and maintain GCP-related SOPs, policies, and quality management systems
Ensure continuous improvement of quality systems, procedures, and training programs
Provide GCP training and ongoing education to clinical and cross-functional staff
Monitor compliance metrics and identify trends and areas for improvement
Act as the liaison between QA and clinical operations, regulatory affairs, and senior leadership
Partner with external stakeholders (e.g., CROs, vendors) to ensure alignment on quality standards
Qualification
Required
BA/BSc in a scientific field with a minimum of 15 years' experience; or MBA or MSc with a minimum of 10 years' experience
10 years of progressive responsibility in Quality Assurance in the Biotechnology industry with at least 5 years' experience in a management or leadership role
Recognized subject matter expert in GCP, GVP, and GCLP and clinical quality systems
Demonstrated ability to drive change within organizations
Demonstrated expert knowledge of FDA regulations, and ICH GCP guidelines. Familiarity with EMA and MHRA regulations
Fast learner, adaptable, with enterprise viewpoint and excellent cross-collaboration and inter-personal skills
Experience managing audits and supporting regulatory inspections
Strong knowledge of clinical trial processes, oncology and/or cell therapy a plus
Ability to work independently and collaboratively among cross-functional teams
Ability to work efficiently, prioritize workflow, meet deadlines and balance competing priorities
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
18 days’ vacation
9 day’s sick leave
8 observed holidays
A floating holiday
Summer and a 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