QA / Computer System Validation (CSV) Lead

About the role

MAESTRO is the eTMF, eISF, CTMS and QMS that our customers are inspected on. When a regulator or sponsor audits one of our customers, our platform — and its validated state — is part of what's under the microscope. This role owns that validated state.

You'll make sure that what we ship stays compliant with ICH E6(R3), 21 CFR Part 11, EU Annex 11 and Health Canada expectations — continuously, not once every eighteen months. MAESTRO's whole differentiator is that every release ships with a freshly regenerated, audit-ready validation package, so the system is never "validated long ago and quietly drifted since." You're central to keeping that promise true.

This is a hands-on quality role for someone who understands that compliance is a feature, not a gate — and who can keep us inspection-ready without slowing the team down.

What you'll do

• Own Computer System Validation (CSV): author and execute IQ/OQ/PQ protocols, traceability matrices and validation summary reports.
• Apply a risk-based, GAMP 5 / CSA approach so we validate what genuinely matters and automate the routine — keeping rigor high and friction low.
• Maintain the SOPs, validation plan and audit-ready evidence package that customers rely on during their own inspections.
• Partner with engineering on change control, release qualification, and deviation / CAPA handling, so quality is built into how we ship.
• Support customer and regulatory audits (Health Canada, FDA, sponsor) — and help our customers pass theirs.

What you'll bring

• 3+ years in QA, validation or compliance for regulated software (clinical, pharma, medical device, or lab).
• Working knowledge of 21 CFR Part 11, EU Annex 11, ICH E6(R3) / GCP and GAMP 5.
• Experience writing and executing validation protocols and managing a controlled documentation set.
• Clear, precise writing and a calm, credible presence in front of auditors.

Nice to have

• Exposure to eTMF / eISF / CTMS / QMS systems.
• Familiarity with Computer Software Assurance (CSA) and risk-based testing.
• Experience in a SaaS / Agile delivery environment.

Education

• A degree in Life Sciences, Pharmacy, Biomedical/Software Engineering, Computer Science or a related scientific or technical field from a recognized post-secondary institution — or equivalent practical experience in a regulated environment that demonstrably matches the level of the role.
• Internationally educated candidates are welcome; foreign credentials should be assessed for Canadian equivalency (e.g. WES, ICAS or a comparable recognized service).
• An asset (not required): formal training or certification in computer system validation, GAMP 5 / CSA, or quality/regulatory affairs.

Location & eligibility

This role is open only to candidates who are based in Canada and legally entitled to live and work in Canada (Canadian citizens, or permanent/legal residents with valid Canadian work authorization). We are not able to sponsor relocation or work authorization for this position.

Why join

You'll define how a modern clinical platform stays inspection-ready every day, not just at release — and your work will directly help research teams pass the audits that keep their trials moving.