Quality Assurance Manager

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.

• 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.

• 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…