Solution Architect – Quality, QMS

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Participate early in the sales cycle to aid in defining requirements and project scoping.

• Oversee comprehensive implementations of the Kivo platform through organized project management and governance.

• Conduct discovery and design workshops.

• Convert regulated process requirements into configured solutions on the platform, ensuring decisions are documented.

• Support customer adoption of Kivo.

• Provide education to customers on Kivo’s validation methodology and guide them through Kivo documentation.

• Collaborate with the Data Migration team on discovery processes, field mapping, dry-run coordination, and production cutover checklists.

• Manage change management initiatives, including defect triage, assessments for go-live readiness, user training enablement, and post-go-live stabilization.

• Act as the primary strategic post-implementation contact for a portfolio of North American accounts.

• Develop and sustain customized success plans that align with customer business objectives.

• Work alongside Sales to identify, qualify, and promote expansion and upsell opportunities.

• Foster senior-level customer relationships while providing executive-ready insights, business reviews, and ROI narratives.

• Gather customer feedback, champion roadmap priorities, and collaborate with Product on features and packaged offerings.

• Oversee customer adoption of new feature releases and configuration adjustments.

• Manage GRR and NRR metrics; implement playbooks for at-risk accounts, renewals, and expansion discussions.

⛳️ Requirements

• 5–10+ years of experience in a customer success, implementation, or blended services role within a life sciences SaaS setting (pharmaceuticals, biotechnology, medical devices, or CRO).

• Strong domain expertise in Quality processes within the pharmaceutical/biotech or medtech sectors.

• Proven history of managing a portfolio of accounts.

• Familiarity with regulated industry requirements (GxP, 21 CFR Part 11 / Annex 11).

• Comfortable supporting validation deliverables (CSA/CSV).

• Experience leading software implementations in a regulated setting, including project planning, stakeholder management, and go-live execution.

• Exceptional written and verbal communication skills in English.

• Comfortable presenting to technical users and C-suite executives.

• Reside in the US with the flexibility to occasionally adjust schedules for EU-based project collaboration.

• Practical AI experience with models such as Claude, ChatGPT, or Copilot for creating workflows, automations, or skills, along with the ability to guide customers in their usage.

• Hands-on experience with life sciences SaaS platforms such as Vault, MasterControl, TrackWise/ETQ, or similar eQMS, eTMF, or RIM systems.

• Previous experience working in hyper-growth, fast-paced environments while managing multiple priorities.

• Bachelor’s degree in computer science or equivalent experience.

🏝️ Benefits

• Balance outside the office.

• PMP, Agile/Scrum certification, or equivalent project management training regarded as a beneficial development qualification.