Software Quality Assurance (SQA) GxP / CSV Programs
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Role Purpose
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.
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Primary Accountability
No release without validated evidence and approved SLC compliance.
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Responsibility
1. SLC & Validation Governance
Ensure mandatory SLC documentation is created, reviewed, and approved
Act as the final quality gate before deployment
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2. CSV Oversight
Ensure end to end traceability (requirements code test evidence)
Oversee deviations, impact assessments, and CAPA
Confirm release readiness and validation completion
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3. Quality Reviews & Compliance Assurance
Verify adherence to client SLC, customer SOPs, and quality standards
Proactively escalate quality, compliance, and regulatory risks
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4. 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
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5. Stakeholder & Audit Interface
Provide visibility on quality health, risks, and trends
Ensure continuity through strong documentation and knowledge transfer
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Decision Authority
Block releases due to compliance or validation gaps
Accept or challenge risk justifications
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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
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