Job Description

Senior QA Manager, Computer Systems Validation (CSV)

Location : Redwood City, CA (on-site)

Contract : 6-month contract (likely to extend/convert to FTE)

The Opportunity:

We are seeking a Computer System Validation (CSV) QA Subject Matter Expert to provide leadership and guidance on global GxP regulations and compliance for computerized systems, electronic records, electronic signatures, and data integrity (21 CFR Part 11, EU Annex 11).

In this role, you will:

• Oversee CSV activities for internal and external electronic systems, ensuring compliance with global regulatory requirements (FDA, GAMP) and RevMed’s Software Development Life Cycle (SDLC) standards.
• Implement best practices for data governance and integrity, ensuring all systems meet GxP compliance standards.
• Lead Quality oversight for Data Integrity and Computer System Validation activities.
• Review and approve CSV deliverables, GxP change management requests, and quality records (e.g., deviations and CAPAs) to ensure adherence to quality standards.
• Conduct QA audits and assessments for supplier qualification or requalification of electronic system service providers.
• Drive process improvements for computerized system policies, procedures, and validation processes.
• Collaborate across teams to identify opportunities for enhancement and implement best practices.
• Provide guidance and training to cross-functional teams on a risk-based approach to GxP system deployment.
• Support inspection readiness initiatives and assist during partner audits and regulatory inspections.

Required Skills, Experience & Education:

• Deep understanding of 21 CFR Part 11, EU Annex 11, and data integrity principles for computerized systems.
• Expertise in GAMP 5, software development lifecycle methodologies, and industry best practices.
• Extensive experience with GxP electronic systems (Clinical Quality Assurance/Compliance experience in a bio-pharma sponsor organization preferred).
• Strong knowledge of data integrity controls, regulatory compliance, and CSV best practices.

Preferred Skills:

• Hands-on experience implementing and maintaining data integrity controls.
• Experience supporting regulatory inspections and audits.
• Proven ability to work with all levels of management and effectively influence key stakeholders.
• Strong written and verbal communication skills.

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