Senior CAPA Manager, Clinical Quality Assurance - Remote

Overview

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.

In Short

• Lead global investigations and support teams with CAPA preparation.
• Manage Quality Issues and serious breach investigations.
• Review, approve Investigations, Root Cause Analysis (RCA), Corrective and Preventive Action (CAPA) and Effectiveness Check (EC) plans.
• Track quality events from Quality Issues, Audits, Inspections.
• Manage quality event updates in eQMS.
• Evaluate policies and procedures for compliance and provide recommendations.
• Support QA initiatives/projects for quality improvements.
• Promote a quality mindset and excellence in all activities.
• Understand and interpret regulatory agencies policies related to GCP.

Requirements

• BA or BS in related field.
• Minimum of 9 years of experience in Quality Assurance.
• Knowledge of QMS system (Veeva preferred).
• GCP QA Certification preferred.
• Experience across all phases of clinical development.
• Knowledge of FDA regulations and ICH guidelines.
• Proficiency in QA tools and software (Veeva preferred).
• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving skills.

Benefits

• Opportunity to work in a mission-driven company.
• Collaborative and inclusive work environment.
• Engagement in innovative vaccine development.