Solution Engineer / Product Lead — GxP
About the role
Be the founder’s second-in-room: run the demos, map the workflows, and walk Heads of Quality through the evidence — with a defined track to Product Lead as our first design partnerships convert.
Every buyer conversation we have is with a Head of Quality, VP Quality, or QA/CSV leader — people who detect hand-waving instantly. Your job is to make Verixa concrete in those rooms. The product is built and internally tested, and we are entering paid design-partner engagements with emerging pharma, biotech and CDMO quality teams — India first, US in parallel. You would be hire #1 in the Hyderabad market team.
About Verixa
Verixa is a governed-AI workflow platform for regulated life sciences, built by Navira Quality Systems. We apply bounded AI assistance inside regulated quality workflows — deviation investigation, RCA, CAPA, audit preparation — with human review, source traceability, controlled approvals and workflow-level audit records on every AI-assisted step. AI can propose; qualified humans determine and approve the regulated decision.
The product is built and internally tested, and we are entering paid design-partner engagements with emerging pharma, biotech and CDMO quality teams — India first, US in parallel. The founder spent 20+ years in pharma quality (Genentech/Roche, BMS, Arcellx, Alumis) and leads every sale personally. You would be hire #1 in the Hyderabad market team.
What you’ll do
- Run the demo — own the demo environment, demo scripts and scenario data. Show a deviation → RCA → CAPA workflow credibly to people who live it daily.
- Map workflows live — sit with a customer’s QA team, take their SOP/process reality, and map it to a bounded Verixa workflow: scope, roles, review gates, exclusions.
- Walk the evidence — present AI output provenance, supporting sources, reviewer history, system records and validation-support documentation, and answer “how would this hold up in an inspection?” without overclaiming.
- Be the founder’s second-in-room — join design-partner meetings, capture what was actually said and agreed, challenge our own optimism, and own same-day follow-ups.
- Feed the product — turn what buyers say into precise input for the product and engineering team: workflow scope, priorities and honest claims. This is where the Product Lead track begins.
The Product Lead track
This role is deliberately built to grow. Prove the solution-engineering seat through our first paid design partnerships, and the product-definition mandate — workflow roadmap, scope decisions, the bridge to our engineering team — formalizes into a Product Lead title. We would rather promote the person who has sat in fifty buyer meetings than hire a product leader who hasn’t.
What we’re looking for
- 4–10 years in pharma/biotech quality reality: plant or clinical QA, CSV/CSA, QMS/eQMS implementation, or quality consulting. You can read a deviation SOP and find the pain in it.
- You can demo software — vendor solution-engineering, implementation consulting, or having led an eQMS/LIMS rollout from the customer side all count.
- You speak both languages — QA (“root cause, impact assessment, Part 11”) and product (“workflow, config, role model”) — and translate between them.
- Startup pace, regulatory discipline — you move quickly without compromising evidence, accuracy or claim discipline.
- Claim discipline — Verixa is internally tested and provides validation-support documentation; each regulated customer remains responsible for validating the system for its intended use within its quality system. If stating that plainly resonates rather than frustrates, you’ll fit.
- Based in Hyderabad, or ready to relocate.
Nice to have
- Exposure to AI/ML tools in a regulated context.
- Annex 11 / Part 11 working knowledge.
- CDMO or sterile-manufacturing background.
- An existing Hyderabad pharma network.
What this role is not
- Not a pure sales quota role — the founder leads sales.
- Not remote.
- Not a support desk.
- It is the most customer-facing technical seat in the company.
What you get
- A ground-floor seat in one of India’s largest life-sciences and pharma hubs, as the market team’s first hire — employed by Navira Quality Systems with meaningful early-employee ESOP.
- Direct daily work with a domain-expert founder; your fingerprints on the product, the demo and the first reference customers — and a defined Product Lead growth track.
- A front-row seat to the evolving AI and computerized-systems regulatory landscape — draft EU Annex 22, Annex 11 developments, FDA Part 11 expectations and, for medical-device applications, FDA CSA.
Compensation. Competitive salary + ESOP, calibrated to experience.
We hire on merit; quality people know evidence beats narrative.