Sr. Specialist, Electronic Quality Management Systems (eQMS)
Lyell Immunopharma
3 days ago
Remote friendly (Bothell, WA)
United States
Operations
Sr. Specialist, eQMS
Key Role and Responsibilities
MasterControl eQMS System Administration:
- Administer user accounts, roles, and permission groups; provision/deprovision access per site SOPs.
- Plan and execute system configuration changes and version upgrades; author/manage MasterControl change controls via the eQMS workflow.
- Design, build, and deploy electronic form solutions to automate and standardize quality data capture and approvals.
- Primary point of contact for system incidents; diagnose and resolve user issues and escalate complex problems to vendor support.
Quality System Process Support:
- Serve as Training Coordinator; configure training assignments mapped to job codes, roles, and user profiles.
- Maintain training records (job codes, personas, trainer groups, course curricula) in the eQMS.
- Backup Document Coordinator; review/edit controlled documents for template conformance, formatting, and grammar prior to release.
- Coordinate with document owners to meet effective dates aligned to quality/regulatory timelines.
- Identify new document types and configure templates; author and complete impact assessments for training/document management sections of change controls.
- Provide quality guidance for deviations, OOS, nonconformance, CAPAs, and change controls.
- Deliver end-user training on quality system processes executed in MasterControl.
Quality Metrics Reporting and Visualization:
- Extract/compile/present quality metrics and KPIs for Management Review, Tier meetings, and Quality Council; ensure data accuracy/traceability.
- Partner with IT/IS to build/maintain quality dashboards.
Preferred Education:
- Bachelor’s (BA/BSc) or equivalent in CS, IS, Microbiology, Biochemistry, Chemical/Bioengineering, or related technical field.
Preferred Experience:
- 10+ years in biopharma/life sciences with regulated GMP technical depth.
- 5+ years in QA/Quality Systems roles in GMP manufacturing or clinical operations.
- hands-on enterprise eQMS system administration (MasterControl/Veeva Vault QMS or equivalent), including configuration, user lifecycle, and validated change control.
Knowledge/Skills/Abilities:
- cGMP system administration required; familiarity with 21 CFR Part 11, Annex 11, and CSV preferred.
- Expertise in eQMS modules and quality event workflows (deviations, CAPAs, change management, document and training management).
- Strong cross-functional collaboration, analytical/problem-solving, organization, communication, and ability to prioritize multiple tasks in a fast-paced biotech environment.
Benefits:
- $124,000–$155,000 annually + annual bonus opportunity; eligible for Equity Incentive Plan.
- Subsidized medical/dental/vision, FSA, Life & AD&D, STD/LTD, ESPP, 401(k) match, commuter benefits, cell phone reimbursement, supplemental benefits, flexible time off, 8 observed holidays, floating holiday, winter office shutdown.
Key Role and Responsibilities
MasterControl eQMS System Administration:
- Administer user accounts, roles, and permission groups; provision/deprovision access per site SOPs.
- Plan and execute system configuration changes and version upgrades; author/manage MasterControl change controls via the eQMS workflow.
- Design, build, and deploy electronic form solutions to automate and standardize quality data capture and approvals.
- Primary point of contact for system incidents; diagnose and resolve user issues and escalate complex problems to vendor support.
Quality System Process Support:
- Serve as Training Coordinator; configure training assignments mapped to job codes, roles, and user profiles.
- Maintain training records (job codes, personas, trainer groups, course curricula) in the eQMS.
- Backup Document Coordinator; review/edit controlled documents for template conformance, formatting, and grammar prior to release.
- Coordinate with document owners to meet effective dates aligned to quality/regulatory timelines.
- Identify new document types and configure templates; author and complete impact assessments for training/document management sections of change controls.
- Provide quality guidance for deviations, OOS, nonconformance, CAPAs, and change controls.
- Deliver end-user training on quality system processes executed in MasterControl.
Quality Metrics Reporting and Visualization:
- Extract/compile/present quality metrics and KPIs for Management Review, Tier meetings, and Quality Council; ensure data accuracy/traceability.
- Partner with IT/IS to build/maintain quality dashboards.
Preferred Education:
- Bachelor’s (BA/BSc) or equivalent in CS, IS, Microbiology, Biochemistry, Chemical/Bioengineering, or related technical field.
Preferred Experience:
- 10+ years in biopharma/life sciences with regulated GMP technical depth.
- 5+ years in QA/Quality Systems roles in GMP manufacturing or clinical operations.
- hands-on enterprise eQMS system administration (MasterControl/Veeva Vault QMS or equivalent), including configuration, user lifecycle, and validated change control.
Knowledge/Skills/Abilities:
- cGMP system administration required; familiarity with 21 CFR Part 11, Annex 11, and CSV preferred.
- Expertise in eQMS modules and quality event workflows (deviations, CAPAs, change management, document and training management).
- Strong cross-functional collaboration, analytical/problem-solving, organization, communication, and ability to prioritize multiple tasks in a fast-paced biotech environment.
Benefits:
- $124,000–$155,000 annually + annual bonus opportunity; eligible for Equity Incentive Plan.
- Subsidized medical/dental/vision, FSA, Life & AD&D, STD/LTD, ESPP, 401(k) match, commuter benefits, cell phone reimbursement, supplemental benefits, flexible time off, 8 observed holidays, floating holiday, winter office shutdown.