Sr. Specialist, Electronic Quality Management Systems (eQMS)

Lyell Immunopharma•Bothell, WA

5d•Onsite

About The Position

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.

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.