Sr. Specialist, Electronic Quality Management Systems (eQMS)

Lyell Immunopharma•Bothell, WA

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. The Sr. Specialist, eQMS serves as the primary system administrator for the MasterControl electronic Quality Management System (eQMS), responsible for system configuration, user administration, lifecycle management, and continuous improvement of the platform and its governed processes. This role also serves as Training Coordinator, provides backup coverage for the Document Coordinator function, and owns the collection, reporting, and visual management of quality metrics and KPIs presented at key site forums at the LyFE site.

Requirements

Hands on experience administering systems in cGMP clinical or commercial manufacturing environments required; familiarity with 21 CFR Part 11, Annex 11, and computer system validation (CSV) principles preferred.
Deep functional expertise with eQMS modules and quality event management workflows (deviations, CAPAs, change management, document control, training management) required.
Demonstrated ability to work effectively both independently and cross-functionally with Manufacturing, MSAT, Regulatory, Patient Operations, Supply Chain, and external partners to define system requirements, manage project plans, and communicate outcomes to stakeholders.
Detail-oriented and organized, with strong analytical and problem-solving skills; able to independently prioritize and manage multiple system administration tasks in a dynamic environment.
Adaptable self-starter with a continuous improvement mindset and the ability to thrive in a fast-paced, clinical-stage biotech environment with evolving system needs.
Excellent written and verbal communication skills; ability to translate technical system concepts for non-technical audiences and prepare clear documentation for GMP-regulated environments.

Nice To Haves

Minimum 10 years’ experience in biopharmaceutical or life sciences environments, with demonstrated technical depth in regulated GMP systems.
Minimum 5 years’ experience in Quality Assurance and Quality Systems roles within GMP manufacturing or clinical operations.
Proven hands on experience as a system administrator for an enterprise eQMS platform (e.g., MasterControl, Veeva Vault QMS, or equivalent); experience with system configuration, user lifecycle management, and validated system change control strongly preferred.
Bachelor’s degree (BA/BSc) or equivalent in Computer Science, Information Systems, Microbiology, Biochemistry, Chemical Engineering, Bioengineering, or a related scientific or technical field.

Responsibilities

Administer user accounts, roles, and permission groups; provision and deprovision access in accordance with site SOPs.
Evaluate, plan, and execute system configuration changes and version upgrades; author and manage all Mastercontrol change controls through the eQMS workflow.
Design, build, and deploy electronic form solutions within MasterControl to automate and standardize quality data capture and approvals.
Serve as the primary point of contact for system incidents; diagnose and resolve user-reported issues and escalate complex technical problems to MasterControl vendor support as needed.
Execute the Training Coordinator function within MasterControl; configure training assignments to ensure accurate mapping to job codes, roles, and user profiles.
Maintain user training records by managing job code assignments, personas, trainer group memberships, and course curricula within the eQMS.
Perform the Document Coordinator role in MasterControl; review and edit controlled documents for template conformance, correct formatting, and grammatical accuracy prior to release.
Coordinate with document owners and stakeholders to meet targeted effective dates, ensuring alignment with quality event drivers and regulatory timelines.
Partner with functional area representatives to identify new document types and configure corresponding templates within the eQMS document management module.
Author and complete impact assessments for the document management and training sections of change controls.
Provide system-level and procedural Quality guidance for quality events including deviations, out-of-specification, nonconformance, CAPAs, and change controls, as applicable.
Deliver end-user training on quality system processes (CAPA, Deviation, OOS, Change Control, etc.) documented and executed within the MasterControl eQMS platform.
Extract, compile, and present quality metrics and KPIs for site governance forums including Management Review, Tier meetings, and Quality Council; ensure data accuracy and traceability to source systems.
Collaborate with IT/IS to design, build, and maintain data visualization dashboards that surface key quality metrics and trend data for site leadership and functional teams.