Join our Mission to Protect Humankind!
Vaxcyte is a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, which have serious and costly health consequences when left unchecked. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.
WHAT we do is every bit as important as HOW we do it! Our work together is guided by four enduring core values:
*RETHINK CONVENTION: We bring creative and intellectual diversity to every facet of the work we do in order to innovate and re-innovate the way vaccines are delivered.
*AIM HIGH: We embody our collectively audacious goal to courageously make the most complex biologics ever attempted to protect humankind.
*LEAD WITH HEART: Everyone leads at Vaxcyte with a kindness-first, inclusive approach to collaboration and vigorous debate that advances our business objectives.
*MODEL EXCELLENCE: The magnitude of our challenge requires our shared commitment to demonstrating integrity, accountability, equality and clarity across communications and decision making.
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: San Carlos, CA
Compensation:
The compensation package will be competitive and includes comprehensive benefits and an equity component.
Salary Range: $169,000 - $197,500 (SF Bay Area). Salary ranges for non-California locations may vary.
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.