Project Manager - LIMS ( GxP / CSV )

End-to-End Project Ownership (Primary)

Governance, RAID, and Decision Management (Primary)

Requirements, Testing, and Validation Coordination (Primary)

Operational Readiness & Adoption (Primary)

Minimum Requirements (Required)

Preferred Qualifications

• Own project delivery from intake and charter through requirements, build coordination, validation/testing, deployment, and hypercare.
• Define and control scope; build integrated plans, milestones, and dependency maps; manage changes through formal change control.
• Drive execution to hit delivery targets set by IT and business stakeholders; escalate early when risks threaten timelines or compliance.
• Establish and run project governance: RAID logs, action tracking, status reporting, steering forums, decision logs, and stakeholder communications.
• Act as the single point of accountability for cross-functional execution across IT, labs, Quality/Validation, and vendors.
• Manage tradeoffs transparently (speed vs. risk vs. cost vs. compliance) and obtain documented approvals.
• Facilitate requirements workshops with lab and quality stakeholders; ensure clear acceptance criteria and traceability.
• Coordinate test strategy and execution (UAT, regression, validation testing) with Quality/Validation; ensure evidence is complete and audit-ready.
• Ensure deliverables align to validated systems expectations (GxP, data integrity, and relevant standards such as 21 CFR Part 11 ISO 17025 where applicable).
• Own cutover planning, training coordination, SOP/work-instruction impacts, and readiness gates for go-live.
• Ensure a supportable release: handoff to support teams, clear escalation paths, and hypercare plans with measurable stabilization targets.
• Drive continuous improvement using post-release metrics (incident reduction, cycle time, adoption feedback).
• Bachelor s degree in IT, Information Systems, Engineering, or related discipline (or equivalent experience).
• 10+ year s experience delivering IT projects (application enterprise systems).
• Demonstrated ownership of governance: RAID, status reporting, stakeholder forums, escalation management.
• Strong facilitation and documentation skills (requirements, acceptance criteria, decision logs).
• Experience operating in high-availability environments (24/7 operations) with urgency and structured incident/release coordination.
• Based in EU; travel up to 20%.
• Experience delivering projects in regulated validated environments (GxP, CSV/CSA, data integrity; Part 11 concepts).
• Experience with Lab/Quality systems (LIMS, CDS, ELN, QMS, MES) and integrations.
• Vendor management (SOWs, milestones, deliverables, acceptance testing).
• Familiarity with change management and training rollouts in lab environments.

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