Associate Director, Clinical Quality Assurance

Summary

Join Vaxcyte, a clinical-stage vaccine innovation company, as an Associate Director, Clinical Quality Assurance! This role requires leading quality oversight of the Adult Phase III Vaccine Program, guiding the Clinical Operations team on multiple Phase III trials, and managing a QA team. You will identify and mitigate risks, ensure compliance with regulations, and support inspection readiness activities. The ideal candidate possesses a strong background in quality management within a clinical setting and a passion for maintaining the highest standards of clinical excellence. This position offers a competitive compensation package, including comprehensive benefits and an equity component.

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 with the ability to manage multiple projects simultaneously
• Demonstrate ability to oversee assigned QA team
• 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
• Strong sense of ownership in areas of responsibility

Responsibilities

• 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 to minimize quality issues
• Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements
• Provide Clinical Quality Assurance updates to Clinical Operations, and Clinical Operations updates to upper QA Management
• Support Inspection Readiness activities for Vaxcyte, Clinical Sites and Clinical Service Providers
• Support in QA initiatives/projects for quality, process improvements
• 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

Preferred Qualifications

GCP QA Certification preferred (RQAP-GCP, or similar)

Benefits

• Competitive compensation package
• Comprehensive benefits
• Equity component
• Salary Range: $172,000 – $201,000 (SF Bay Area)
• Salary ranges for non-California locations may vary