Associate Director, 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. Working to eradicate or treat bacterial infections such as invasive pneumococcal disease, Group A Strep, periodontitis and Shigella is just the beginning. Our path to success is clear and well-defined, and Vaxcyte is set up to go the distance.

In Short

• Lead quality oversight of Adult Phase III Vaccine Program.
• Provide guidance to Clinical Operations team on multiple Phase III trials.
• Manage a team of 1-4 QA employees dedicated to the Adult Vaccine Program.
• Identify potential risk associated with study design/execution and collaborate with subject matter experts to implement mitigation strategies.
• Evaluate policies and procedures for compliance with applicable regulations/guidelines.
• Provide Clinical Quality Assurance updates to Clinical Operations.
• Support Inspection Readiness activities for Vaxcyte, Clinical Sites and Clinical Service Providers.
• Support in QA initiatives/projects for quality, process improvements.
• Promote a quality mindset and quality excellence approach to all activities.
• Understand and interpret regulatory agencies policies and guidance as it pertains to GCP requirements.

Requirements

• BA or BS in related field.
• Minimum of 10 years of experience in Quality Assurance within the clinical or pharmaceutical industry.
• Experience in oversight of Phase III vaccine trials.
• Demonstrate in-depth knowledge of GCPs, FDA and EU requirements and ICH guidelines.
• Experience across all phases of clinical development.
• Strong project management skills.
• Demonstrate ability to oversee assigned QA team.
• GCP QA Certification preferred.
• Proficiency in QA tools and software (Veeva preferred).
• Excellent communication and interpersonal skills.
• Strong analytical and problem-solving skills.

Benefits

• Competitive compensation package.
• Comprehensive benefits.
• Equity component.
• Relocation assistance available.