UST
Website:
ust.com
Job details:
Role Description
IT Program Manager - LIMS Sample Lifecycle & Data Integrity (GxP, Multi-Site, 24/7 Operations)
Position Summary
This role owns
, inspection-critical delivery of LIMS Sample Management capabilities across EU/ROW in a
GxP-regulated, multi-site laboratory network.
The Lead PM is accountable for
end-to-end sample lifecycle integrity, ensuring
defensible, audit-ready data flows from sample intake through archival and disposal. This includes
ownership of system design decisions, validation strategy, and operational risk tradeoffs impacting 24/7 lab execution.
Unlike standard PM roles, this position requires
direct accountability for regulatory exposure, data integrity risk, and inspection outcomes, not just delivery milestones.
The Role Operates At The Intersection Of:
- Laboratory operations (high-throughput, time-sensitive workflows)
- Quality & Validation (CSV/CSA, inspection readiness)
- Enterprise IT & integrations (LIMS, instruments, middleware)
- Regulatory compliance (GxP, ALCOA+, 21 CFR Part 11)
Core Accountabilities (Non-Delegable Ownership)
- End-to-End Sample Lifecycle Architecture & Delivery
- Own global design and delivery of Sample Manager workflows:
- Registration, aliquoting, pooling, chain-of-custody, storage, archival, disposal
- Translate lab operational constraints into system-enforced workflows
- Ensure no uncontrolled manual steps that compromise traceability
- Maintain integrated delivery plans spanning instruments, middleware, and LIMS layers
Elevated Expectation:
Demonstrated ownership of
workflow standardization across multiple labs, not just single-site implementation.
- Data Integrity & Regulatory Defensibility (Critical Accountability)
- Own implementation of ALCOA+ principles in system design and process flows
- Ensure complete traceability across system boundaries (LIMS instruments external systems)
- Design and defend:
- Audit trails
- Electronic signatures
- Data lineage and reconciliation controls
- Partner with QA to ensure inspection-ready data flows under real audit scrutiny
Elevated Expectation:
Candidate must have
personally supported or defended systems during regulatory inspections (FDA, MHRA, EMA, etc.)
- Governance Under Compliance Constraints
- Establish multi-layer governance model:
- RAID, decision logs, validation traceability matrices
- Steering forums with documented decision authority
- Act as final escalation point for:
- Compliance vs speed tradeoffs
- Data integrity risks
- Operational disruption risks
- Enforce formal change control with regulatory impact assessment
Elevated Expectation:
Evidence of
decision ownership in high-risk scenarios, not just facilitation.
- Validation Strategy & Execution Leadership (CSV CSA Transition)
- Own validation lifecycle:
- Requirements traceability
- Risk-based validation strategy (CSA-aligned where applicable)
- Test design, execution oversight, deviation management
- Ensure end-to-end traceability: requirement test evidence approval
- Deliver audit-defensible validation packages
Elevated Expectation:
Experience transitioning or operating within
CSA (Computer Software Assurance) frameworks.
- Operational Continuity in 24/7 Lab Environments
- Design and execute zero-disruption releases for live lab operations
- Own:
- Cutover strategy
- Rollback planning
- Hypercare stabilization metrics
- Define and monitor:
- Sample turnaround time impact
- Error rates
- Throughput degradation risks
Elevated Expectation:
Demonstrated delivery in
high-throughput or time-critical lab environments where downtime has material impact.
- Multi-Site / Global Harmonization
- Drive global standardization vs local regulatory accommodation
- Balance:
- Site-specific workflows
- Enterprise LIMS strategy
- Own cross-site dependency management and rollout sequencing
Elevated Expectation:
Experience delivering across
3 sites with differing regulatory or operational constraints
- Vendor & Ecosystem Orchestration
- Own vendor delivery across:
- LIMS platforms (e.g., Thermo Fisher SampleManager, LabWare, LabVantage)
- Instrument integration providers
- Enforce SOW accountability tied to measurable outcomes
- Manage integration risks across lab instrumentation and data pipelines
Elevated Expectation:
Evidence of
holding vendors accountable for failed delivery or rework
Success Metrics (Audit-Level Ownership)
- Zero critical data integrity findings in inspections
- End-to-end sample traceability completeness (no orphan or untracked samples)
- Validation:
- Cycle time
- Right-first-time documentation
- Operational:
- Sample turnaround time (pre vs post release)
- Error/rework rate reduction
- Delivery:
- Milestone adherence under change control
- Inspection outcomes:
- No major/critical observations linked to system or process design
Hard Requirements (Strict Gates)
- 10-15+ years enterprise IT delivery in regulated environments
- Proven ownership of LIMS Sample Manager or equivalent sample lifecycle systems
- Demonstrated end-to-end program ownership (not module-level contribution)
- Direct experience with:
- GxP, ALCOA+, 21 CFR Part 11
- CSV and/or CSA validation frameworks
- Evidence of:
- Inspection readiness or audit defense involvement
- Governance leadership (RAID, steering, escalation decisions)
- Experience supporting 24/7 operational environments
- Multi-site/global delivery experience
Scarcity Signals (Strong Differentiators)
Candidates With These Signals Should Be Prioritized:
- Direct involvement in regulatory inspections (audit defense, not observation only)
- Ownership of data integrity remediation programs
- Experience with lab automation & instrument integrations
- Proven global LIMS harmonization initiatives
- Transition experience from CSV CSA
- Handling critical incidents affecting lab operations (production-impacting)
Explicit Anti-Patterns (Reject Signals)
- Supported or coordinated LIMS projects without ownership
- Validation involvement limited to documentation tracking
- No evidence of data integrity ownership
- Single-site experience only
- No measurable operational or compliance outcomes
- IT-only roles with no lab or QA partnership exposure
Role Archetype (Explicit)
Primary: Delivery / Execution (Program-Level)
Secondary Overlay: Governance / Compliance-Critical Execution
Skills
program management,regulatory domain,data integrity,sample management,lab instrumentation,regulatory analysis,
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