Principal Global LIMS & ELN System Specialist
About The Position
About the role: The Principal Global LIMS & ELN System Specialist represents lab stakeholders and defines the strategy, roadmap, and validation plan for the Global LIMS & ELN. The person will leads cross‑functional delivery and vendor management to ensure the system is validated, adopted, and operationally successful. Your responsibilities will include: Global governance: define SOPs, master data standards, role‑based access, and harmonized workflows for all labs. Validation ownership: own IQ/OQ/PQ strategy, approve validation deliverables, and sign off go‑live and major upgrades. Vendor management: work with supplier quality to negotiate SLAs, manage escalations, and enforce vendor evidence requirements for releases and security attestations. Customization policy: set configuration vs customization rules and approve any custom development with business case and QA review. Change control: chair the global change control board, prioritize cross‑BU requests, and enforce testing and rollback criteria. Data migration & integrations: own migration acceptance criteria, instrument/API priorities, and traceability between ELN records and LIMS sample data. Training & adoption: define global training strategy, regional super‑user programs, and adoption KPIs. Risk & compliance: lead system risk assessments, accept residual risk, and escalate to executive sponsors when needed. Supports other preclinical systems as available. What we're looking for in you: Minimal requirements 10+ years in lab informatics, LIMS/ELN implementations, or lab operations. Deep experience with COTS LIMS/ELN deployments, supplier management, and computerized system validation (IQ/OQ/PQ). Strong regulatory knowledge (GxP, 21 CFR, ISO 13485) and audit experience. Proven ability to influence cross‑functional stakeholders without direct line authority. Technical fluency with integrations, data migration, and cloud or on‑prem LIMS architectures.
Requirements
- 10+ years in lab informatics, LIMS/ELN implementations, or lab operations.
- Deep experience with COTS LIMS/ELN deployments, supplier management, and computerized system validation (IQ/OQ/PQ).
- Strong regulatory knowledge (GxP, 21 CFR, ISO 13485) and audit experience.
- Proven ability to influence cross‑functional stakeholders without direct line authority.
- Technical fluency with integrations, data migration, and cloud or on‑prem LIMS architectures.
Responsibilities
- Global governance: define SOPs, master data standards, role‑based access, and harmonized workflows for all labs.
- Validation ownership: own IQ/OQ/PQ strategy, approve validation deliverables, and sign off go‑live and major upgrades.
- Vendor management: work with supplier quality to negotiate SLAs, manage escalations, and enforce vendor evidence requirements for releases and security attestations.
- Customization policy: set configuration vs customization rules and approve any custom development with business case and QA review.
- Change control: chair the global change control board, prioritize cross‑BU requests, and enforce testing and rollback criteria.
- Data migration & integrations: own migration acceptance criteria, instrument/API priorities, and traceability between ELN records and LIMS sample data.
- Training & adoption: define global training strategy, regional super‑user programs, and adoption KPIs.
- Risk & compliance: lead system risk assessments, accept residual risk, and escalate to executive sponsors when needed.
- Supports other preclinical systems as available.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
Number of Employees
5,001-10,000 employees
