ABOUT US

Bhrigu is a US-based startup building next-generation software platforms for regulated and non-regulated manufacturing and laboratories. Our products operate in GxP and non-GxP environments, requiring strong engineering discipline, validation readiness, and security-by-design.

We're building a new product for digital manufacturing and digital lab environments — software that pharma, biotech, medical device, and food manufacturers will run their operations on, and that their quality and validation teams will need to trust before it ever touches a production line or a lab bench.

Here, you won't just be a cog in the machine — you'll be part of building the machine. If you thrive in environments where you can wear multiple hats, roll up your sleeves, and see your work through from start to finish, this is your prospect to make a real impact.

WHAT YOU WILL DO

This is a 0-to-1 role. There is no existing quality or validation function to inherit — you are building it, for a product that doesn't exist yet, for customers who will not sign a contract until they trust it. That means two jobs that are usually separate are combined here: software quality assurance (does the product work, release over release) and computer system validation (can a regulated customer prove it works, to their auditor, forever).

You'll define our test strategy and quality gates as the product is built, and in parallel you'll define our validation approach — GAMP 5 categorization, risk-based validation planning, IQ/OQ/PQ protocols, requirements traceability, and 21 CFR Part 11 and data integrity controls — so that the product ships audit-ready rather than retrofitted for compliance after the fact. You'll work directly with engineering on the first, and directly with customers' quality and validation teams on the second.

WHAT SUCCESS LOOKS LIKE

In your first six months, we expect you to:

- Stand up a test strategy and quality gate process the engineering team actually follows, with defined coverage targets for [N] core modules.
- Deliver a GAMP 5 categorization and a Validation Master Plan for the new product.
- Produce a working set of IQ/OQ/PQ protocol templates and a requirements traceability matrix ready to execute against.
- Complete a 21 CFR Part 11 / data integrity (ALCOA+) gap assessment against the product as built, with a remediation plan for anything open.
- Be the person a prospective customer's QA or validation lead can talk to directly during due diligence, and hold up.

DUTIES AND RESPONSIBILITIES:

Software Quality Assurance

- Define and own the test strategy for the new product — functional, regression, integration, and where appropriate automated testing.
- Build or specify the test automation framework and drive coverage as the product grows, rather than testing everything by hand indefinitely.
- Own release quality gates:



define what "ready to ship" means and hold the line on it.
- Run defect management — triage, prioritization, root cause, and closure — in partnership with engineering.
- Embed quality practices into the SDLC itself (shift-left) rather than treating QA as a final gate before release.

Computer System Validation & Compliance

- Determine GAMP 5 category and appropriate validation approach (CSV or risk-based CSA) for the product and its components.
- Own the Validation Master Plan, including risk assessments, validation protocols, and the requirements traceability matrix.
- Author and execute (or oversee execution of) IQ/OQ/PQ protocols and associated validation documentation.
- Ensure the product's audit trail, e-signature, and access control features meet 21 CFR Part 11 and Annex 11 requirements.
- Own data integrity practice (ALCOA+) across the product's data lifecycle.

Quality Systems & Customer Trust

- Build and maintain the SDLC and quality documentation a regulated customer's auditor will actually ask to see.
- Own change control and deviation management for the software development process.
- Serve as the technical point of contact for customer quality/validation due diligence, security questionnaires, and audits.
- Prepare and maintain the standard validation package (vendor assessment materials, Part 11 compliance matrix, GAMP 5 documentation) that every prospective customer's validation team will eventually request.

Everything Else

- Wear multiple hats to support whatever a successful product launch actually requires — this function doesn't exist yet, so its shape is partly yours to define.

WHAT YOU WILL BRING

Experience

- ·7+ years in software quality assurance, computer system validation, or a combined quality/compliance role for regulated (GxP) software.
- Direct, hands-on experience with GAMP 5, computer system validation (CSV), and/or FDA's risk-based Computer Software Assurance (CSA) approach.
- Practical experience writing and executing IQ/OQ/PQ protocols and requirements traceability matrices — not just familiarity with the terms.
- Working knowledge of 21 CFR Part 11, Annex 11, and data integrity principles (ALCOA+).
- Experience building or running a software test strategy, including test automation, for a real production product.
- Comfortable being the person in the room when a customer's QA or validation lead asks hard questions — you can hold your own without an SME standing behind you.
- Strong technical writing — this role produces documents that get read by auditors.

Nice to Have





- Experience at a MES, LIMS, QMS, or similar software vendor — Veeva, MasterControl, Sparta/TrackWise, Körber, ValGenesis, Kneat, or comparable.
- ASQ CSQE/CQA, ISTQB, or equivalent quality certification.
- Experience validating cloud/SaaS systems specifically, where traditional on-premise CSV assumptions don't cleanly apply.
- Familiarity with ISO 13485 or 21 CFR Part 820, if our roadmap moves toward medical device manufacturing customers.
- Experience with test automation and QA tooling (e.g., Selenium, Playwright, TestRail, Azure DevOps, Jira).
- Prior experience as the named quality contact during a customer or regulatory audit.

LOCATION AND TRAVEL

- Remote within the United States.
- Expect occasional travel for customer audits, validation walkthroughs, and industry conferences — typically under 15%.
- Must be authorized to work in the United States without visa sponsorship.

Why Join Us (vs. a Big Company)??

True Ownership - You'll help design and build a platform from the group up. Every feature, every decision, every improvement - you'll be part of it.

Mission-Driven Work – We’re solving critical problems in pharma manufacturing that improve safety, compliance, and efficiency.

· Accelerated Growth– With us, you’ll learn faster, stretch your skills, and take on challenges that would take years to access elsewhere.

· Startup Energy, Real Impact– No red tape. No silos. Just smart, motivated people building something meaningful together.

· End-to-End Visibility– Be part of the full journey — from whiteboard to deployment — and actually see how your work changes the game.

- Build category-defining productsfor regulated life sciences
- Work on cutting-edge AI + vector searchin real-world GxP environments
- High ownership, real impact, and direct collaboration with US leadership
- Opportunity to influence platform architecture from early stages

Why You’ll Love It Here??

Here are some things you will be a part of:

· Build foundational products with real-world impact in life sciences.

· Work directly with founders and be part of early product leadership.

· Flexible remote work, async-friendly culture.

· Competitive equity, startup perks, and growth opportunities.

· Help define the culture of a product-first, purpose-driven startup.

Job Type: Full-time

Benefits:

- Cell phone reimbursement
- Health insurance
- Internet reimbursement
- Paid sick time
- Paid time off
- Work from home

Experience:

- software quality assurance or computer system validation: 7 years (Required)
- GAMP5, CSV, and/or FDA's risk-based CSA: 3 years (Required)
- writing/executing IQ/OQ/PQ protocols: 3 years (Required)
- working knowledge of 21 CFR Part 11, Annex 11, and ALCOA+: 3 years (Preferred)
- building/running software test strategy: 3 years (Preferred)

Work Location: Remote

📌 Software Quality & Validation Lead (India)
🏢 Bhrigu
📍 India