Senior Manager, 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 global investigations and support teams with CAPA preparation in compliance with applicable regulations/guidelines.
• 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 quality events from Quality Issues, Audits, Inspections or similar QA activities.
• Manage/oversee quality event updates in eQMS.
• Evaluate policies and procedures for compliance and provide recommendations for improvements.
• Support QA initiatives/projects for quality and process improvements.
• Promote a quality mindset to all activities.
• Interpret regulatory agencies policies and assist in implementing compliant processes.

Requirements

• BA or BS in related field.
• Minimum of 9 years of experience in Quality Assurance in the clinical or pharmaceutical industry.
• Knowledge of QMS system (Veeva preferred).
• GCP QA Certification preferred (RQAP-GCP, or similar).
• Experience across all phases of clinical development.
• Knowledge of FDA regulations and ICH guidelines.
• 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.