Senior Manager, Validation, IT, Quality and Compliance - Remote

Overview

Vaxcyte is seeking an experienced and proactive Senior Manager of Validation to lead validation activities for computerized systems, ensuring compliance with regulatory requirements and internal quality standards.

In Short

• Oversee Computer Software Assurance (CSA) and validation processes for computerized systems.
• Manage and execute validation plans, protocols, and reports for IT systems.
• Collaborate with cross-functional teams for project lifecycles.
• Conduct risk assessments and validation impact analyses.
• Develop and maintain validation deliverables.
• Lead periodic reviews of validated systems.
• Drive vendor qualification activities.
• Support audits by preparing validation documentation.
• Train and mentor teams on validation best practices.
• Identify and resolve QC-related issues.

Requirements

• Bachelor’s degree in a related field.
• Master’s degree preferred.
• Minimum 8 years of experience in IT validation.
• Strong expertise in validating GxP systems.
• Proven experience with CSA methodologies.
• Knowledge of regulatory standards.
• Experience conducting vendor assessments.
• Exceptional project management skills.
• Strong analytical and problem-solving capabilities.
• Excellent communication skills.

Benefits

• Innovative work environment.
• Collaborative team culture.
• Opportunity to impact public health.
• Professional development opportunities.
• Competitive compensation package.