Lyell Immunopharma
Healthcare
Sr.Specialist,ElectronicQualityManagementSystems(eQMS)
“Sr. Specialist, Electronic Quality Management Systems (eQMS) at Lyell Immunopharma. Skills: MasterControl eQMS System Administration, Quality System Process Support, Quality Metrics Reporting and Visualization. Serve 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.. Serve as Training Coordinat”
What You'll Achieve.
Ensure accurate mapping to job codes, roles, and user profiles.; Meet targeted effective dates, ensuring alignment with quality event drivers and regulatory timelines.; Surface key quality metrics and trend data for site leadership and functional teams.
Industry & Context.
Analytical and problem-solving able to independently prioritize and manage multiple system administration tasks in a dynamic environment.; Diagnose and resolve user-reported issues; Escalate complex technical problems
What They're Looking For.
Must Have
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., Hands on experience administering systems in cGMP clinical or commercial manufacturing environments, Deep functional expertise with eQMS modules and quality event management workflows (deviations, CAPAs, change management, document control, training management) required.
Nice to Have
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., Familiarity with 21 CFR Part 11, Annex 11, and computer system validation (CSV) principles preferred.
What You'll Do.
Serve as the primary system administrator for the MasterControl electronic Quality Management System (eQMS)
responsible for system configuration
and continuous improvement of the platform and its governed processes.
Serve as Training Coordinator.
Provide backup coverage for the Document Coordinator function.
and visual management of quality metrics and KPIs presented at key site forums at the LyFE site.
Administer user accounts
and permission provision and deprovision access in accordance with site SOPs.
and execute system configuration changes and version.
Author and manage all Mastercontrol change controls through the eQMS workflow.
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 diagnose and resolve user-reported issues and escalate complex technical problems to MasterControl vendor support as needed.
Execute the Training Coordinator function within configure training assignments to ensure accurate mapping to job codes
Maintain user training records by managing job code assignments
trainer group memberships
and course curricula within the eQMS.
Perform the Document Coordinator role in review and edit controlled documents for template conformance
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
Deliver end-user training on quality system processes (CAPA
etc. ) documented and executed within the MasterControl eQMS platform.
and present quality metrics and KPIs for site governance forums including Management Review
Ensure data accuracy and traceability to source systems.
Collaborate with IT/IS to design
and maintain data visualization dashboards that surface key quality metrics and trend data for site leadership and functional teams.
How You'll Work.
Team & Collaboration
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.; 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.; Respectfully challenge each other
Communication Scope
Excellent written and verbal communication ability to translate technical system concepts for non-technical audiences and prepare clear documentation for GMP-regulated environments.
Process & Methodology
Manage project plans
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