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Senior Manager, Clinical Quality Assurance - Remote

Posted 1 week ago
All others
Full Time
CA, USA
$158,000 - $185,000/year

Overview

We are seeking a dedicated and experienced Senior Manager, Clinical Quality Assurance, to join our dynamic team at Vaxcyte. The ideal candidate will have a strong background in quality management within a clinical setting and a passion for maintaining the highest standards of clinical excellence.

In Short

  • Lead global investigations and support teams with CAPA preparation.
  • Manage Quality Issues and serious breach investigations.
  • Review, approve Investigations, RCA, CAPA and EC plans.
  • Track quality events from Quality Issues, Audits, Inspections.
  • Manage quality event updates in eQMS.
  • Evaluate policies for compliance and recommend improvements.
  • Support QA initiatives/projects for quality improvements.
  • Promote a quality mindset and quality excellence approach.
  • Understand and implement compliant processes regarding GCP.

Requirements

  • BA or BS in related field.
  • Minimum of 9 years of experience in Quality Assurance.
  • Knowledge of QMS system (Veeva preferred).
  • GCP QA Certification preferred.
  • 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.
Vaxcyte logo

Vaxcyte

Vaxcyte is a clinical-stage vaccine innovation company dedicated to engineering high-fidelity vaccines aimed at protecting humankind from serious bacterial diseases. With a focus on eradicating or treating infections such as invasive pneumococcal disease, Group A Strep, periodontitis, and Shigella, Vaxcyte is committed to addressing the significant health consequences of these conditions. The company operates under four core values: rethinking convention, aiming high, leading with heart, and modeling excellence, which guide their collaborative and innovative approach to vaccine development. Vaxcyte is positioned for success in the biotechnology sector, emphasizing quality assurance and regulatory compliance in its operations.

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