Manager, IT Quality & Compliance
Confirmed live in the last 24 hours
Vaxcyte
Job Description
Join our Mission to Protect Humankind!
Summary:
Vaxcyte’s IT team is seeking a motivated, forward-thinking Manager, IT Quality & Compliance to support executing and supporting IT Quality, Compliance, and Validation (CSV/CSA) activities across GxP systems. This role partners closely with the Director of IT Quality & Compliance to operationalize the IT QSC (Quality, Security, Compliance) strategy and ensure systems remain compliant, secure, and audit-ready. This is a hands-on role requiring expertise in IT system validation, auditing, vendor management, and compliance operations within a regulated GxP environment.
Essential Functions:
IT Validation & CSV/CSA Execution
- Execute Computer Software Assurance (CSA) and Computer System Validation (CSV) activities for GxP systems
- Support validation lifecycle activities (planning, testing, documentation, release, and change management)
- Provide ITQA oversight for implementation of GxP systems
- Support data migration validation (reconciliation, traceability, and verification)
Audit & Inspection Readiness
- Perform internal IT CSV audits to ensure regulatory and procedural compliance
- Support and execute GxP vendor audits
- Prepare audit documentation, evidence packages, and formal audit reports
- Support regulatory inspections and inspection readiness activities
Vendor Management & Oversight
- Conduct vendor qualification and periodic vendor audits
- Support vendor risk assessments and compliance monitoring
- Ensure vendors meet GxP, data integrity, and security requirements
Periodic Reviews & Compliance Monitoring
- Perform periodic reviews of GxP systems to maintain validated state
- Identify compliance gaps and drive remediation
- Support continuous audit and compliance monitoring programs
Investigations & CAPA Management
- Support IT investigations (deviations, incidents, compliance gaps)
- Author and manage CAPAs, ensuring timely closure and effectiveness
- Partner cross-functionally to implement corrective and preventive actions
Documentation & SOP Development
- Author and maintain IT and QA SOPs, policies, and work instructions
- Ensure alignment with GxP and 21 CFR Part 11 requirements
- Support continuous improvement of documentation and processes
Data Integrity, Cybersecurity & Infrastructure Alignment
- Support implementation of data integrity controls (ALCOA+)
- Pa