Solution Architect – Quality, QMS

Job Description:

• Engage early in the sales process to assist with requirements definition 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 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 the Data Migration team on discovery, field mapping, dry-run coordination, and production cutover checklists
• Guide change management activities including 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 and maintain tailored success plans aligned with customer business goals
• Partner with Sales to identify, qualify, and advance expansion and upsell opportunities
• Cultivate senior-level customer relationships and deliver executive-ready insights, business reviews, and ROI narratives
• Surface customer feedback, advocate for roadmap priorities, and collaborate with Product on features and packaged offerings
• Manage customer adoption of new feature releases and configuration changes
• Own GRR and NRR metrics; execute playbooks for at-risk accounts, renewals, and expansion conversations

Requirements:

• 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 of Quality process in the pharmaceutical/biotech or medtech industries
• Demonstrated track record managing across a portfolio of accounts
• Working knowledge of regulated industry requirements (GxP, 21 CFR Part 11 / Annex 11)
• 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
• Based in the US with flexibility to occasionally time-shift for EU-based project collaboration
• Applied AI experience with AI models such as Claude, ChatGPT, or Copilot to build workflows, automations, or skills, and ability to guide customers in their use
• Hands-on experience with life-sciences SaaS platforms such as Vault, MasterControl, TrackWise/ETQ, or comparable eQMS, eTMF, or RIM systems
• Prior experience working in hyper-growth, fast-paced environments and 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 mentioned as a nice-to-have development qualification