QA/GxP Contractor — Acting Quality Lead

Navira Quality Systems (Verixa platform) · Remote (India-led) · Contract

Pharma/Biotech SaaS Quality · QMS ownership · 6-month contract, renewable · ~2–3 days/week · Remote

About Navira Quality Systems:

Navira Quality Systems is the company behind Verixa — an AI-governed Quality Management System (eQMS) purpose-built for pharmaceutical, biotech, and other regulated life-sciences organisations. Verixa brings validation, quality, documentation, and audit-readiness into one modern, compliant platform designed around 21 CFR Part 11, EU Annex 11, ISO, and emerging AI-governance expectations. We are a focused, fast-moving team building software where quality and trust are the product.

About The Role:

We're seeking a seasoned QA/GxP professional to act as our quality lead — standing up the Verixa quality management system to effectivity and operating it through our first design-partner pilot. You'll be the independent quality approver: reviewing and approving procedures, running training governance, and owning deviation/CAPA and management review as the platform moves toward ISO and SOC 2 readiness.

What You'll Do:

• Review and approve the priority SOP suite to effectivity — document control first, then the ISO/SOC 2-critical procedures — with comments resolved and approval signatures per procedure.
• Stand up training governance: role-based curricula and documented completion records.
• Operate the QMS through the pilot: deviation and CAPA handling, document change control, and quality risk register upkeep.
• Chair and minute the first management review and contribute to quarterly quality reviews.
• Support the quality agreement for the design-partner pilot, keeping a clear vendor / customer validation boundary.
• Own the CAPA / nonconformity register as procedures become effective.

What we are Looking for?

• 8+ years in pharma/biotech QA with genuine QMS ownership (document control, training, deviation/CAPA, management review).
• Experience holding SOP / controlled-document approval authority.
• GxP SaaS or computerized-systems quality exposure.
• Working knowledge of ICH Q10 and quality risk management.

Nice to Have:

• eQMS vendor-side experience.
• ISO 27001 / SOC 2 program exposure.
• Quality-agreement negotiation and audit hosting.
• Awareness of AI-in-QMS governance (e.g., draft Annex 22).

Engagement Details:

• Independent contractor engagement (deliverable-based), with delegated, documented QA approval authority.
• Initial term: 6 months, renewable.
• Commitment: ~2–3 days/week through SOP effectivity and the pilot window; lighter in steady-state.
• Location: remote-first, India-led.
• Compensation: competitive, commensurate with experience.
• A confidentiality agreement (NDA) is signed before access is granted.

Why This Role?

This is a rare chance to shape a modern eQMS from the quality seat — setting the standards, approvals, and disciplines that a regulated platform is built on, with direct influence over its first customer pilot.

How to Apply?

Send your CV/profile and a short note on relevant experience to [email protected] with the subject line “QA/GxP Acting Quality Lead Contractor – Verixa”, or apply directly through this LinkedIn post. We review applications on a rolling basis.

Navira Quality Systems is an equal-opportunity organisation. We welcome applicants of all backgrounds and are committed to a fair, inclusive hiring process.