Regulatory Life-Sciences Solutions Architect

Kivo; United States; Remote; USD 140,000 - 210,000; Full time

Job summary

Kivo is seeking a senior Solution Architect to lead post-sale success for pharmaceutical customers in the US, with occasional EU support. You will own implementations, drive outcomes, and partner with clients to achieve long-term value.

In this role you will design and configure regulated workflows, support validation, data migration, and change management, while maintaining executive relationships and guiding cross-functional teams toward growth and retention.

Qualifications

• 5–10+ years of experience in a customer success, implementation, or blended services role within a life-sciences SaaS environment (pharma, biotech, med-device, or CRO).
• Strong domain knowledge in Regulatory Affairs or Operations for pharmaceutical/biotech or medtech industries is a must
• Demonstrated track record managing across a portfolio of accounts.
• Working knowledge of regulated industry requirements (GxP, 21 CFR Part 11 / Annex 11) and comfort supporting validation deliverables (CSA/CSV).
• 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 alike.
• Based in the US with the flexibility to occasionally time-shift for EU-based project collaboration.
• Applied AI experience with AI models (e.g., Claude, ChatGPT, Copilot) to build workflows, automations, or skills and the ability to guide customers in their use - not just as an end user

Responsibilities

• Lead end-to-end implementations of the Kivo platform through structured project management and governance.
• Design and configure: translate regulated process requirements (GxP, 21 CFR Part 11 / Annex 11) into configured platform solutions with documented decisions and adoption guidance.
• Support the customer’s validation workstream by educating customers in the Kivo validation methodology.
• Support data migration with discovery, field mapping, dry-run coordination, and production cutover checklists.
• Guide customers through change management activities: defect triage, go-live readiness, user training enablement, and post-go-live stabilization.
• Own account health and drive outcomes and expansion by aligning success plans with business goals.
• Cultivate executive-level relationships and deliver ROI narratives to reinforce Kivo’s value.
• Proactively manage upgrades and adoption to ensure continued platform utilization and growth.
• Retain and grow the base by managing GRR and NRR, renewals, and expansion conversations in coordination with Sales leadership.

Skills

Customer success

Implementation leadership

Regulatory affairs knowledge

Project management

English communication

AI workflow design

Education

Bachelor's degree in computer science or equivalent

Tools

eQMS / RIM platforms

Job description

Kivo is seeking a senior Solution Architect to lead post-sale success for pharmaceutical customers in the US, with occasional EU support. You will own implementations, drive outcomes, and partner with clients to achieve long-term value.

In this role you will design and configure regulated workflows, support validation, data migration, and change management, while maintaining executive relationships and guiding cross-functional teams toward growth and retention.