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+).
- 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.
Training & Cross-Functional Collaboration
- Support IT Quality & Compliance training initiatives.
- Collaborate across IT, Security, Quality, and business teams.
- Promote a culture of compliance, quality, and audit readiness.
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)
- Internal and vendor audits
- Periodic reviews of GxP systems
- Vendor management and oversight
- 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
Preferred:
- 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.
Reports to: Director, IT Quality & Compliance
Location: Open to Remote; San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $169,000 - $198,00 (SF Bay Area). Salary ranges for non-California locations may vary.