Manager, IT Quality & Compliance

Vaxcyte•San Carlos, CA

9h•Onsite

About The Position

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.

Requirements

Bachelor’s degree in IT, Quality, Life Sciences, or related field and minimum 5 years of experience in IT Quality, CSV/CSA, or compliance in a GxP environment. Other combinations of education and/or experience may be considered.
Hands-on experience with: IT system validation (CSV/CSA)
Hands-on experience with: Internal and vendor audits
Hands-on experience with: Periodic reviews of GxP systems
Hands-on experience with: Vendor management and oversight
Hands-on experience with: Data migration validation
Experience supporting or working with laboratory (GxP lab) and manufacturing systems (e.g., MES, LIMS, lab instruments)
Experience with Veeva, ERP systems, or regulated SaaS platforms
Experience supporting or implementing GxP systems from a QA perspective
Strong knowledge of GxP, 21 CFR Part 11, and data integrity principles
Experience authoring SOPs, validation documentation, CAPAs, and investigations

Nice To Haves

Experience in life sciences or biotech environments
Experience writing and presenting audit reports and familiarity with risk management frameworks
Exposure to QSC (Quality, Security, Compliance) integration and knowledge of data governance and data integrity practices
Working knowledge of cybersecurity (access control, data protection, incident response)
Exposure to IT security and infrastructure controls (patching, system hardening)
Experience using AI tools for research, analysis, and process optimization

Responsibilities

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)
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
Conduct vendor qualification and periodic vendor audits
Support vendor risk assessments and compliance monitoring
Ensure vendors meet GxP, data integrity, and security requirements
Perform periodic reviews of GxP systems to maintain validated state
Identify compliance gaps and drive remediation
Support continuous audit and compliance monitoring programs
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
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
Support implementation of data integrity controls (ALCOA+)
Partner with IT Security to align compliance with cybersecurity controls (access, logging, monitoring)
Ensure infrastructure supporting GxP systems is maintained in a secure and compliant state (patching, backup, recovery)
Identify and escalate risks related to data integrity, cybersecurity, and infrastructure
Support IT Quality & Compliance training initiatives
Collaborate across IT, Security, Quality, and business teams
Promote a culture of compliance, quality, and audit readiness