Solution Architect - Regulatory (RIM)
解决方案架构师是一位高级，面向客户的领导者，拥有深入的制药监管背景，他拥有基沃公司客户的完整售后旅程。该职位的主要重点是通过主动成功管理来推动客户的结果，保留和扩张，从引领实践实施项目开始到持续到客户成功互动。你将与基沃公司的客户建立深刻，可信的关系，带领实现长期成功的客户并作为他们的战略合作伙伴。这一角色在监管环境中发展出战略账户管理和运营交叉点。虽然主要集中于美国，但该职位可能需要偶尔调整时间来支持基于欧盟的实施项目和客户。关键责任 执行咨询与基沃的美国实施团队合作：·解决方案设计：参与早期销售过程以协助定义要求和项目范围；·实现：通过结构化项目管理和治理领导基沃平台端到端实施。·设计 &配置：促进发现和设计研讨会；支持验证：通过向客户提供基沃验证方法和对基沃文档的指导，支持客户的验证工作流程。·支持数据迁移：与数据迁移团队合作于发现，现场地图化，干燥运行协调和生产切断检查清单进行合规数据传输。·启动直播：通过变化管理活动引导客户：故障分类，直播准备评估，用户培训启用以及直播后稳定。客户成功与副总裁合作，服务：· 个人账户健康：管理 NA 帐户组合作为实施后的主要战略联系点 · 推动结果和扩张：建立并维护根据每个客户的业务目标定制的成功计划；与销售合作确定，资格化，促进你的投资组合内的扩展和升级机会。· 执行协调：培养高级层面的关系。
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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
Originally posted on Himalayas