Senior Capa Manager, Clinical Quality Assurance

Summary

Join Vaxcyte, a clinical-stage vaccine innovation company, as a Senior CAPA Manager, Clinical Quality Assurance! This role requires a strong background in quality management within a clinical setting and a passion for maintaining the highest standards of clinical excellence. You will lead global investigations, manage quality issues, review CAPA plans, track quality events, and evaluate policies for compliance. The ideal candidate will have at least 9 years of experience in Quality Assurance within the clinical or pharmaceutical industry and knowledge of QMS systems (Veeva preferred). This position offers a competitive compensation package, including comprehensive benefits and an equity component, with a salary range of $158,000-$185,000 in the SF Bay Area. The location is San Carlos, CA, but remote work may be considered.

Requirements

• BA or BS in related field
• Minimum of 9 years of experience in Quality Assurance within the clinical or pharmaceutical industry
• Knowledge of QMS system (Veeva preferred)
• 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

Responsibilities

• Lead global investigations and support teams with CAPA preparation in compliance with applicable regulations/guidelines, customer requirements, Standard Operating Procedures (SOPs) and project specific guidelines/instructions
• 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 until closure quality events from Quality Issues, Audits, Inspections or during similar QA activities
• Manage/oversee quality event update in eQMS
• Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements
• 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: $158,000 – $185,000 (SF Bay Area)
• Open to remote