Manager, It Quality & Compliance

Vaxcyte Inc

San Carlos, CA, United States
Base: $169,000 - $197,500; bonus/equity: equity co...
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Computer system validation csv csa execution
Gxp regulatory compliance and audits
Vendor qualification and risk management
** Vaxcyte Inc is seeking a Manager of IT Quality & Compliance to oversee IT Quality, Compliance, and Validation activities in a GxP environment. The role requires expertise in IT system validation, auditing, and vendor management, emphasizing a hands-on approach to ensure compliance and audit readiness. **

Job Summary

  • Vaxcyte is seeking a Manager to operationalize IT Quality, Security, and Compliance strategies for GxP systems.
  • The role requires hands-on expertise in executing Computer Software Assurance and Computer System Validation activities across the validation lifecycle.
  • Candidates must ensure audit readiness, manage vendor compliance, and drive data integrity practices within a regulated environment.

Matching Summary

Match Score: 75

** Vaxcyte Inc is seeking a Manager of IT Quality & Compliance to oversee IT Quality, Compliance, and Validation activities in a GxP environment. The role requires expertise in IT system validation, auditing, and vendor management, emphasizing a hands-on approach to ensure compliance and audit readiness. **

Salary

Base: $169,000 - $197,500; Bonus/Equity: Equity component included; Benefits: Comprehensive benefits package

Skills & Requirements

Must-have

  • Computer System Validation CSV CSA execution
  • GxP regulatory compliance and audits
  • Vendor qualification and risk management
  • CAPA management and investigations
  • Data integrity ALCOA+ principles
  • SOP authoring and maintenance

Nice-to-have

  • Experience with Veeva or ERP systems
  • Knowledge of cybersecurity controls
  • Life sciences or biotech background
  • AI tools for process optimization
  • Cross-functional collaboration skills

Key Requirements

  • Bachelor's degree in IT, Quality, or Life Sciences
  • Minimum 5 years experience in IT Quality or CSV/CSA
  • Experience with laboratory and manufacturing systems like MES or LIMS

Work Rights

Not specified

Tailored Resume

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