Director of Quality Assurance

4 weeks ago


Boston, Massachusetts, United States Aveo Pharmaceuticals Inc Full time
Job Title: Director of Quality Assurance

About the Role:

We are seeking a highly experienced Director of Quality Assurance to join our team at Aveo Pharmaceuticals Inc. As a key member of our quality leadership team, you will be responsible for ensuring the highest standards of quality and compliance across all stages of product development and commercialization.

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.
* Demonstrated knowledge of international regulatory requirements for biotech products and experience in disposition of biotech products to multiple jurisdictions.
* Utilizes strong organizational, interpersonal and communication skills to plan and accomplish goals.
* Proven experience in leading quality assurance teams and managing complex quality systems.

About Aveo Pharmaceuticals Inc:

Aveo Pharmaceuticals Inc is a commercial-stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. We are committed to creating an environment of diversity, equity and inclusion to diversify representation within the Company. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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