Own end-to-end implementations of the Kivo platform for biopharma and med-device customers
Plan & deliver multiple implementations concurrently: project charter and plan, timelines, RAID, status, risk/issue escalation, stakeholder communications, and executive readouts
Facilitate discovery & design workshops; translate regulated process requirements into configured solutions and documented decisions
Own validation workstream with a risk-based approach: author/review plans, requirements, test protocols, traceability, deviations, and final reports aligned to 21 CFR Part 11 / Annex 11
Drive change management: defect triage, go-live readiness, training enablement, and post-go-live support
Partner cross-functionally with Sales, Customer Success, Support, and Product to deliver value and ensure smooth hand-offs
Own scope & quality: SOW adherence, acceptance criteria, and measurable outcomes (time-to-value, CSAT, on-time delivery)
Oversee data migrations and integrations, training, and post-go-live stabilization consistent with life-sciences best practices
Requirements
5–8+ years delivering enterprise software implementations for life-sciences (e.g., eQMS, eTMF, RIM, CTMS, EDMS)
Vendor or consulting background (Veeva, MasterControl, IQVIA, or similar)
Demonstrated ownership of validation in regulated environments (GxP; 21 CFR Part 11 / Annex 11) and creation of CSV/CSA deliverables
Hands-on experience with data migrations and integrations (APIs/iPaaS)
Configuration experience of SaaS quality/regulatory systems
Strong project leadership: multi-workstream delivery, stakeholder management, status/risk communications; PMP a plus
Excellent facilitation and documentation skills; comfortable performing design, testing, and cutover tasks
Experience with Vault, MasterControl, TrackWise/ETQ or related platforms (nice to have)
Familiarity with eClinical and regulatory content processes (submission/registration, TMF, deviations/CAPA, training) (nice to have)
PSA/Jira/Confluence proficiency; prior consulting or SI experience (nice to have)
Located in the United States; Portland, OR location or remote (U.S. required)