Sr. Manager, Clinical Quality Assurance

September 7

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Vaxcyte

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Vaxcyte is a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases$1. .$1

51 - 200

Description

• Provide GCP compliance oversight and support to the clinical program and clinical study team. • Collaborate with cross-functional teams to address quality issues and implement corrective actions. • Contributes to the development, maintenance, and implementation of GCP-related policies and SOPs. • Conduct and support GCP audits of clinical vendors and investigator sites, as applicable. • Support inspection readiness activities and make recommendations for continuous improvements. • Assists in constructing annual GCP trainings. • Promotes a quality mindset and quality excellence approach to all activities. • Understands and interprets regulatory agencies policies and guidance as it pertains to GCP requirements and assists in the implementation of compliant processes at Vaxcyte.

Requirements

• BA or BS in related field. • GCP QA Certification preferred (RQAP-GCP, or similar). • Minimum of 7 years of experience in Quality Assurance within the clinical or pharmaceutical industry, or within Clinical Operations. • Experience across all phases of clinical development. • Knowledge of applicable FDA regulations and ICH guidelines. • Proficiency in QA tools and software (Veeva preferred). • Excellent communication and interpersonal skills, with the ability to work collaboratively with diverse teams. • Strong analytical and problem-solving skills, with a keen attention to detail.