Digital R&D - Delivery Excellence Lead
Core
Operational enabler empowering Software Engineering and Agile Product teams to embed compliance (GxP, Data Privacy, Cybersecurity, AI) into the Software Development Life Cycle (SDLC) and Solution Life Cycle (SLC) through engineer-friendly approaches.
Role type
Senior IC Delivery Excellence Lead (Compliance Enablement)
Builds
Compliant, high-quality software deliverables and System Lifecycle artifacts for Digital R&D Hub teams
Domain
Life Sciences / BioPharma / Regulated IT
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
Computer System Validation (CSV) for GxP systems, FDA 21 CFR Part 11, EU Annex 11, Data Integrity (ALCOA++), GAMP 5, Agile/DevOps in regulated environments, Cloud/SaaS validation, risk-based validation, Computer System Assurance (CSA), cross-functional team leadership
Preferred skills
Experience managing teams of Delivery Excellence Specialists, tooling adoption for documentation and traceability
Technologies
Cloud/SaaS platforms, Agile/DevOps tooling
Responsibilities
Enable teams to own compliance rather than acting as gatekeepers, guide teams in creating compliant System Lifecycle deliverables, perform control monitoring and compliance health checks, provide compliance metrics and actionable insights, coach teams on maintaining audit-ready practices, deliver practical training on risk domains and control activities
Seniority
Senior, hands-on IC with team management responsibilities
