Solution Architect – Regulatory, RIM
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Job Description
Solution Architect leading Kivo’s regulated life-sciences SaaS implementations and validation support. Owning North American customer success, retention, adoption, and expansion.
Responsibilities:
- Engage early in the sales process to assist with requirements definition and project scoping
- Lead end-to-end Kivo platform implementations through structured project management and governance
- Facilitate discovery and design workshops
- Translate regulated process requirements into configured platform solutions with documented decisions
- Guide customer adoption of Kivo
- Educate customers on Kivo’s validation methodology and orient them to Kivo documentation
- Partner with Data Migration on discovery, field mapping, dry-run coordination, and production cutover checklists
- Guide change management, defect triage, go-live readiness assessments, user training enablement, and post-go-live stabilization
- Manage a portfolio of North American accounts as the primary strategic post-implementation contact
- Build tailored success plans aligned with customer business goals
- Partner with Sales to identify, qualify, and advance expansion and upsell opportunities
- Cultivate senior customer relationships and deliver executive-ready insights, business reviews, and ROI narratives
- Represent customer feedback internally and collaborate with Product on roadmap priorities, features, and packaged offerings
- Manage feature releases and configuration changes to ensure adoption and platform utilization
- Own GRR and NRR metrics; execute playbooks for at-risk accounts, renewals, and expansion conversations with Sales leadership
Requirements:
- 5–10+ years of experience in a customer success, implementation, or blended services role within a life-sciences SaaS environment
- Strong domain knowledge in Regulatory Affairs or Operations for pharmaceutical/biotech or medtech industries
- Demonstrated track record managing a portfolio of accounts
- Working knowledge of GxP, 21 CFR Part 11, and Annex 11
- Comfort supporting CSA/CSV validation deliverables
- Experience leading software implementations in a regulated environment, including project planning, stakeholder management, and go-live delivery
- Excellent written and verbal communication skills in English
- Comfortable presenting to technical users and C-suite stakeholders
- Based in the US with flexibility to occasionally time-shift for EU-based project collaboration
- Applied AI experience with models such as Claude, ChatGPT, or Copilot to build workflows, automations, or skills, and ability to guide customers in their use
- Bachelor’s degree in computer science or equivalent experience
- Ability to work in a fast-paced environment and manage shifting priorities
- Systems-thinking mindset and curiosity to understand the “why”
- Focus and commitment to customer success
- Hands-on experience with life-sciences SaaS platforms such as Vault, MasterControl, TrackWise/ETQ, or comparable eQMS, eTMF, or RIM systems is nice to have
- Prior hyper-growth experience and PMP, Agile/Scrum certification, or equivalent project management training are nice to have
Benefits:
- Customer success, retention, and expansion ownership
- Opportunity to build trusted customer relationships and serve as a strategic partner
- Professional development through hands-on implementation, validation, and regulated-industry work
- Work with AI models including Claude, ChatGPT, and Copilot to build workflows, automations, or skills
- Ability to maintain a balance outside the office
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