Responsibilities
- Define and execute end-to-end Quality technology strategy across R&D and TOQ; align to QMS processes, lifecycle requirements, and governance.
- Own lifecycle of Quality applications/platforms, including Veeva Quality Suite, LabWare LIMS, SAP S/4 QM (Quality modules), and other Quality/compliance systems (selection, implementation, integration, enhancement, retirement).
- Ensure IT platforms are reliable, scalable, and aligned to GxP/Quality standardization and continuous improvement.
- Partner with enterprise architecture, infrastructure, cybersecurity, and digital risk teams to align with IT standards.
- Oversee QMS-enabling IT delivery and ongoing support; retain end-to-end oversight of vendor work; establish governance, performance management, and accountability.
- Enable Quality data strategy and integration (data models, standards, integration patterns; enterprise data platform integration; data governance, lineage, and quality for GxP data).
- Enable analytics/AI for Quality (QMS performance monitoring, risk identification/predictive quality insights, predictive analytics for system health/capacity/operational risk).
- Ensure GxP compliance, validation, and data integrity; support CSV/system assurance and audit/inspection readiness; establish scalable system lifecycle management processes.
- Serve as primary IT partner to Quality leadership; translate priorities into roadmaps and solutions; support standardization/simplification/scalability; enable adoption and change management; build a high-performing Quality Technology team.
Required Qualifications
- B.S./M.S./Ph.D. in science or engineering.
- 15+ years IT experience supporting Quality in life sciences.
- Strong GxP/Quality/regulatory understanding; enterprise system implementation leadership (e.g., Veeva, Labware, SAP).
- Solid enterprise systems/data/integration knowledge.
- Proven senior leader partnership; regulated environment/audit-inspection exposure.
Preferred Qualifications
- Snowflake or other enterprise data platforms; data integration patterns.
- Enterprise Data/AI collaboration; analytics/reporting/AI use cases in Quality.
- Experience with system architecture/integration/technology strategy; data governance/data integrity frameworks.
- End-to-end product lifecycle experience.
Benefits (as stated)
- U.S. pay range: $226,800.00β$306,800.00; eligible for annual short- and long-term incentives.
- Medical/dental/vision, life/disability, lifestyle reimbursement, FSA/HSA, 401(k) with match, paid time off, wellness days, holidays, recharge breaks, and family resources/leaves.