Senior Manager, Clinical Quality Assurance

Vaxcyte seeks an experienced Senior Manager of Clinical Quality Assurance to lead quality investigations, audits, and compliance activities across clinical development programs. The role requires expertise in regulatory standards, quality management systems, and clinical operations to support the organization's vaccine development mission.

Responsibilities

• Lead global investigations and manage CAPA preparation aligned with regulatory requirements and SOPs
• Review and approve investigation plans, root cause analyses, and effectiveness checks
• Plan and conduct risk-based and for-cause audits of clinical sites, CROs, and GCP vendors
• Track quality events to closure and manage updates in electronic quality management system
• Support regulatory inspection readiness including mock inspections and gap assessments

Requirements

• Bachelor's degree in related field
• Minimum 9 years quality assurance experience in clinical or pharmaceutical industry
• Proficiency with QMS systems, preferably Veeva
• GCP QA certification (RQAP-GCP or equivalent) preferred
• Experience across all phases of clinical development
• Knowledge of FDA regulations and ICH guidelines