Director, Clinical Quality Assurance

Lyell Immunopharma•South San Francisco, CA

7d•$200,000 - $245,000•Hybrid

About The Position

Using living cells to treat – and sometimes even cure – cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However, these profound results have not yet been achieved in patients with solid tumors, representing approximately 90% of all cancers. And for patients with hematologic malignancies, there is a need for next-generation cell therapies that can deliver increased response rates and longer duration of response. We are a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. Lyell’s product candidates are enhanced with novel technology designed to generate T cells that resist exhaustion and have qualities of durable stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response. We were founded by cell therapy pioneers whose decades of research elevated the broader understanding of T-cell biology and its interaction with cancer. In our quest to advance next-generation CAR T-cell therapies, we have built a fully integrated company capable of discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients. Our culture is based on Science, Respect, Collaboration, and Courage and reflects who we are, the environment we create, and our mission's urgency. Using living cells to treat – and sometimes even cure – cancer is one of the most dramatic advances in modern medicine. Patients with hematologic malignancies have been successfully treated with cell therapies. However, these profound results have not yet been achieved in patients with solid tumors, representing approximately 90% of all cancers. And for patients with hematologic malignancies, there is a need for next-generation cell therapies that can deliver increased response rates and longer duration of response. We are a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with solid tumors or hematologic malignancies. Lyell’s product candidates are enhanced with novel technology designed to generate T cells that resist exhaustion and have qualities of durable stemness in order to drive durable tumor cytotoxicity and achieve consistent and long-lasting clinical response. We were founded by cell therapy pioneers whose decades of research elevated the broader understanding of T-cell biology and its interaction with cancer. In our quest to advance next-generation CAR T-cell therapies, we have built a fully integrated company capable of discovering new technologies, translating science into therapies, manufacturing cell therapy products, and clinically evaluating them in patients. Our culture is based on Science, Respect, Collaboration, and Courage and reflects who we are, the environment we create, and our mission's urgency. This role is a hybrid role and will be based out of our South San Francisco, California. The individual in this role is responsible for leading and managing our clinical quality systems and ensuring GCP (Good Clinical Practice) compliance across all clinical trial activities. This role will partner across the clinical development organization to establish, maintain, and enhance robust risk-based clinical quality programs that support our investigational products in development. This is a hands-on leadership role suited for someone who thrives in a fast-paced, dynamic environment and is excited to build and optimize quality systems from the ground up.

Requirements

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

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.