Software Quality Assurance (SQA) � GxP / CSV
Katalyst CRO • Waukegan, Illinois, United States
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Role & seniority
- SQA (Quality Authority / Senior SQA) for regulated software initiatives; serves as final quality gate for releases.
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Stack/tools
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Regulatory/quality frameworks: 21 CFR Part 11, GAMP5, Computer System Validation (CSV), Client System Life Cycle (SLC)
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Quality governance artifacts: SLC documentation, validation evidence, deviation/impact assessment, CAPA
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(No specific software/tooling named in the text.)
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Top 3 responsibilities
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SLC & CSV governance: Ensure mandatory SLC docs are created/reviewed/approved; ensure release readiness with validated evidence.
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End-to-end traceability & risk management: Verify requirements → code → test → evidence traceability; oversee deviations, impact assessments, and CAPA.
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Quality/compliance assurance & decisioning: Confirm adherence to SLC/SOP/quality standards; escalate risks and block/accept/challenge release risk justifications.
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Must-have skills
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Strong knowledge of CSV, SLC, 21 CFR Part 11, GAMP5
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Ability to assess compliance gaps and ensure audit-ready documentation
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Competence in traceability, validation evidence review, and CAPA/deviation oversight
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Clear judgment as quality gate/decision authority
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Nice-to-haves
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Experience balancing compliance vs. delivery timelines (right-sized documentation/validation planning)
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Skills in stakeholder management and audit interface (quality
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Full Description
Job Description
The SQA is the quality authority for regulated software initiatives, ensuring that all changes, releases, and deployments comply with Client System Life Cycle (SLC) requirements, Computer System Validation (CSV) expectations, and global regulatory standards (e.g., 21 CFR Part 11, GAMP5).
The role balances compliance, delivery enablement, and risk-based decision-making, enabling predictable and audit ready releases.
Responsibilities
"No release without validated evidence and approved SLC compliance.”
SLC & Validation Governance
Ensure mandatory SLC documentation is created, reviewed, and approved. Act as the final quality gate before deployment.
CSV Oversight
- Ensure end to end traceability (requirements → code → test → evidence).
- Oversee deviations, impact assessments, and CAPA.
- Confirm release readiness and validation completion
Quality Reviews & Compliance Assurance
Verify adherence to client SLC, customer SOPs, and quality standards. Proactively escalate quality, compliance, and regulatory risks.
Delivery Enablement
- Guide teams on right-sized documentation (avoid over/under validation).
- Validate documentation effort estimates and validation planning.
- Partner with delivery to enable compliance without execution delays.
- Ensure validation readiness ahead of major releases and go lives.
Stakeholder & Audit Interface
Provide visibility on quality health, risks, and trends. Ensure continuity through strong documentation and knowledge transfer.
Decision Authority
Block releases due to compliance or validation gaps. Accept or challenge risk justifications.
Key Success Measures
Zero critical audit/review observations attributable to SQA gaps. On time releases with approved SLC & validation artifacts. High first-time right documentation quality. Early identification and mitigation of compliance risks.
