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Added 11 mins ago
Senior Embedded Software Designer
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Full-time
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RAN BioLinks

QA & Compliance Specialist - Clinical Systems

Toronto, ON, Canada
Greater Toronto Area, Canada, Canada

Job type: Full-time
Apply by: Oct 10, 2026
Posting language: English
Posted: Jul 17, 2026

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Original job description

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. Somebody has to be able to stand behind that state with evidence. This role owns it.

Most vendors treat validation as a one-time event: a thick binder produced at go-live, signed off, and then quietly allowed to drift as the product changes underneath it. We built MAESTRO on the opposite premise. Every release ships with a freshly regenerated, audit-ready validation package - traceability intact, evidence current, nothing stale. That is our differentiator, and it only holds if someone owns the discipline behind it. 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 (GUI-0104 / GUI-0029) - continuously, not once every eighteen months.

This is a hands-on quality role for someone who genuinely believes that compliance is a feature, not a gate - who can hold rigor high while keeping friction low, and who can keep us inspection-ready without ever becoming the reason the team slows down. You'll be the person who can look an auditor in the eye and show, on demand, exactly why the system does what it's supposed to.

What you'll do

Own Computer System Validation (CSV) end to end: author, execute and maintain IQ/OQ/PQ protocols, requirements traceability matrices (RTM) and validation summary reports so every requirement maps to a test and every test maps to evidence.
Apply a risk-based, GAMP 5 / CSA approach - assess and categorize functionality by patient-safety and data-integrity risk, validate what genuinely matters, and automate the routine so rigor stays high and testing stays lean.
Build and maintain the automated validation tooling that regenerates the evidence package on every release, so validation keeps pace with delivery instead of lagging months behind it.
Own the controlled documentation set - SOPs, the validation master plan, work instructions and the audit-ready evidence package - keeping it versioned, reviewed, approved and inspection-ready at all times.
Partner with engineering on change control, release qualification, deviation and CAPA management, embedding quality into how we ship rather than bolting it on afterward.
Safeguard data integrity (ALCOA+) and 21 CFR Part 11 controls - audit trails, electronic signatures, access controls and system security - and verify they hold across releases.
Support customer and regulatory audits (Health Canada, FDA, sponsor and CRO qualification audits), respond to findings, and actively help our customers pass their own inspections using our evidence.
Feed quality signals back into the product - turning recurring findings, near-misses and auditor questions into concrete, preventive improvements.

What you'll bring

3+ years in QA, validation or compliance for regulated software (clinical, pharma, medical device, or lab / diagnostics).
Working knowledge of 21 CFR Part 11, EU Annex 11, ICH E6(R3) / GCP, GAMP 5 and data-integrity (ALCOA+) principles.
Demonstrated experience writing and executing validation protocols (IQ/OQ/PQ) and managing a controlled documentation set through its full lifecycle.
Fluency with risk-based thinking - you can defend, in writing, why something was or wasn't tested to a given depth.
Clear, precise, audit-grade writing and a calm, credible presence in front of auditors and inspectors - you make evidence easy to follow and hard to argue with.
A collaborative instinct: you'd rather help engineering build quality in than police it after the fact.

Nice to have

Direct exposure to eTMF / eISF / CTMS / QMS systems, either as a validator or a power user.
Familiarity with Computer Software Assurance (CSA) and risk-based, critical-thinking-led testing.
Experience validating software in a SaaS / continuous-delivery / Agile environment (validation that keeps up with frequent releases).
Comfort with automation - scripting or tooling that turns manual validation steps into repeatable, self-documenting evidence.
Experience supporting or hosting regulatory or sponsor audits first-hand.

Education

Minimum: a Canadian Bachelor's degree (baccalauréat) in Life Sciences, Pharmacy, Biomedical/Software Engineering, Computer Science or a related scientific or technical field - or a college diploma / advanced diploma (DEC, 2–3 years) in a relevant program combined with significant experience in a regulated environment.
An asset (not required): a Master's degree (maîtrise) or doctorate (PhD) in a life-sciences, pharmaceutical or related discipline; or formal training / 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).

Why join

You'll define how a modern clinical platform stays inspection-ready every day, not just at release - and you'll build the systems that make that repeatable instead of heroic. Your work won't sit in a binder on a shelf; it's the evidence customers lean on when a regulator walks in, and it directly helps research teams pass the audits that keep their trials moving. If you've ever wanted validation to be a genuine product capability rather than a compliance chore, this is that role.

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More about this job

Responsibilities

You will own the end-to-end Computer System Validation process, ensuring the platform remains audit-ready and compliant with regulatory standards. You will also partner with engineering to embed quality into the release cycle and support regulatory audits.

Requirements

Candidates must have at least 3 years of experience in QA or validation for regulated software and a strong working knowledge of GAMP 5 and 21 CFR Part 11. A relevant bachelor's degree in a scientific or technical field is required, along with the legal right to work in Canada.

Skills

Computer System Validation
CSV
GAMP 5
21 CFR Part 11
EU Annex 11
ICH E6(R3)
Data Integrity
ALCOA+
Quality Assurance
Regulatory Compliance
Risk-based Testing
SOP Development
Audit Support
Change Control
CAPA Management
Automated Testing

Visa sponsorship

Not detected in the job text

Keywords

QA
Compliance
CSV
Clinical Systems
eTMF
eISF
CTMS
QMS
Validation
IQ/OQ/PQ
RTM
GAMP 5
CSA
21 CFR Part 11
EU Annex 11
ICH E6(R3)
ALCOA+
SOP
CAPA
Audit
FDA
Health Canada
SaaS
Agile
Continuous Delivery
Life Sciences
Biotechnology
Data Integrity
Quality Management
Regulatory Affairs

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