Digital R&D - Delivery Excellence Specialist
Core
Operational enabler embedding GxP compliance and risk management into the Software Development Life Cycle (SDLC) for Digital R&D teams, fostering 'Compliance by Design' rather than acting as a gatekeeper.
Role type
Senior IC compliance enablement specialist (GxP/CSV)
Builds
Compliant software deliverables and validated computerized systems within the Life Sciences R&D domain
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, cross-functional stakeholder management
Preferred skills
Experience with modern engineering practices, tooling adoption for traceability, coaching teams on audit-ready practices
Technologies
Cloud/SaaS platforms, Agile tools, Validation tooling
Responsibilities
Enable teams to own compliance activities aligned with Digital Risk frameworks, guide teams in creating compliant System Lifecycle deliverables, perform control monitoring and compliance health checks, support audit and assurance activities, deliver training on risk domains and control activities
Seniority
Senior, hands-on IC
