Director of Quality Assurance

4 weeks ago


Boston, Massachusetts, United States AVEO Oncology Full time
Job Summary

The Director of Quality Assurance at AVEO Oncology reports to the Vice President Quality Assurance and is responsible for Quality Operations at AVEO including quality strategic leadership and compliance activities related to the cGMP manufacture and release of AVEO products. This position requires a high level of expertise in the industry, ensuring that all processes align with US, EU, and other applicable regional regulations including ICH Guidelines.

Key Responsibilities
  • Develop and implement a robust Supplier Quality Management System that ensures all outsourced GMP operations are in compliance with all relevant regulations and industry standards.
  • Provide strategic direction and oversight of Quality Assurance activities across all stages of product development and commercialization.
  • Lead cross-functional initiatives to promote a culture of continuous improvement, quality excellence, and regulatory compliance.
  • Serve as a key member of the Quality Leadership Team, contributing to the development of company-wide strategies and objectives.
Requirements
  • A minimum of 10 years GMP QA management experience in the Biotech/Pharmaceutical industry.
  • Experience preparing for and hosting regulatory inspections. Previous experience in responding to regulatory inspections preferred.
  • A BS degree in a scientific discipline is required; a post-graduate degree is highly desirable.
  • Extensive knowledge of GMP guidelines, regulatory requirements, and industry best practices.
  • Utilizes strong organizational, interpersonal and communication skills to plan and accomplish goals.
  • Proven experience in leading quality assurance teams and managing complex quality systems.


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