Solution Architect - Regulatory (RIM)

Position Description

The Solution Architect is a senior, customer-facing leader with a deep background in Pharmaceutical Regulatory who owns the full post-sale journey for Kivo’s customers. The primary focus of this role is driving customer outcomes, retention, and expansion through proactive success management that starts with leading hands-on implementation projects and continues through to Customer Success interactions. You will build deep, trusted relationships with Kivo’s customers, lead implementations that set customers up for long-term success and serve as their strategic partner throughout their time with Kivo. This role thrives at the intersection of strategic account management and operational delivery in regulated environments. While primarily US-focused, the role may require occasional time-shifting to support EU-based implementation projects and customers.

Key Responsibilities

Implementation Consulting

Working in partnership with Kivo’s US based implementation team:

• Solution Design: Engage early in the sales process to assist with the definition of requirements and project scoping
• Deliver implementations: Lead end-to-end implementations of the Kivo platform through structured project management, and governance.
• Design & configure: Facilitate discovery and design workshops; translate regulated process requirements (GxP, 21 CFR Part 11 / Annex 11) into configured platform solutions with documented decisions and guide the adoption of Kivo.
• Support validation: Support the customer’s validation workstream by educating customers in the Kivo validation methodology and providing an orientation to Kivo documentation.
• Support data migration: Partner with the Data Migration team on discovery, field mapping, dry-run coordination, and production cutover checklists for compliant data transfers.
• Enable go-live: Guide customers through change management activities: defect triage, go-live readiness assessments, user training enablement, and post-go-live stabilization.

Customer Success

Working in partnership with the VP, Services:

• Own account health: Manage a portfolio of NA accounts as the primary strategic point of contact post-implementation
• Drive outcomes and expansion: Build and maintain tailored success plans aligned to each customer’s business goals; partner with Sales to identify, qualify, and advance expansion and upsell opportunities within your portfolio.
• Executive alignment: Cultivate senior-level relationships within customer organizations; deliver executive-ready insights, business reviews, and ROI narratives that reinforce Kivo’s value.
• Champion the customer: Serve as the primary voice of Kivo customers to the internal team—surface product feedback, advocate for roadmap priorities, and collaborate with Product on features and packaged offerings that reflect NA market needs.
• Manage upgrades and adoption: Proactively manage customers through new feature releases and configuration changes, ensuring smooth adoption and building internal champions who drive platform utilization.
• Retain and grow the base: Own GRR and NRR metrics for your portfolio; develop and execute playbooks for at-risk accounts, renewals, and expansion conversations in coordination with Sales leadership.

What You’ve Done

Required

• 5–10+ years of experience in a customer success, implementation, or blended services role (e.g. Delivery Lead) 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

Nice to Have

• Hands-on experience with life-sciences SaaS platforms such as Vault (Quality/RIM/Clinical), MasterControl, TrackWise/ETQ, or comparable eQMS, eTMF, or RIM systems.
• Prior experience working in hyper-growth, fast-paced environments and managing multiple priorities
• PMP, Agile/Scrum certification, or equivalent project management training.

Who You Are

• Education: Bachelor’s degree in computer science or equivalent experience.
• Drive: The ability and desire to work in a fast-paced environment and manage shifting priorities and maintain a balance outside the office, this is not 9/9/6.
• Curiosity: Systems thinking mindset, and a curiosity to learn and understand the “why”
• Work Ethic: A focus and commitment to customer success