Solution Architect - Regulatory (RIM)

Kivo • Boston, MA

1d • Remote

About The Position

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.

Requirements

• 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 Haves

• 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.

Responsibilities

• Engage early in the sales process to assist with the definition of requirements and project scoping
• Lead end-to-end implementations of the Kivo platform through structured project management, and governance.
• 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 the customer’s validation workstream by educating customers in the Kivo validation methodology and providing an orientation to Kivo documentation.
• Partner with the Data Migration team on discovery, field mapping, dry-run coordination, and production cutover checklists for compliant data transfers.
• Guide customers through change management activities: defect triage, go-live readiness assessments, user training enablement, and post-go-live stabilization.
• Manage a portfolio of NA accounts as the primary strategic point of contact post-implementation
• 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.
• Cultivate senior-level relationships within customer organizations; deliver executive-ready insights, business reviews, and ROI narratives that reinforce Kivo’s value.
• 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.
• Proactively manage customers through new feature releases and configuration changes, ensuring smooth adoption and building internal champions who drive platform utilization.
• 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 This Job Offers

• Job Type: Full-time
• Career Level: Senior