GMP Quality Director

3 days ago


Cambridge, Massachusetts, United States Jobot Full time
Job Responsibilities

We are looking for a highly skilled Senior Quality Assurance Lead to lead our quality assurance efforts. In this critical role, you will be responsible for developing and implementing quality policies and procedures that align with regulatory requirements and industry standards. Your expertise will ensure that our quality systems meet the highest standards and support our mission to deliver safe and effective treatments to patients.

Key responsibilities include providing quality oversight for our clinical development programs and manufacturing processes, managing GMP suppliers, conducting document reviews, investigating and evaluating potential quality impacts from product complaints and temperature excursions, and ensuring inspection readiness at our GMP suppliers. Additionally, you will provide quality review and feedback on regulatory application submissions and agency responses/information requests. Continuous improvement of quality and compliance practices will also be an essential part of this role.

Approximately 10-20% of the time will be spent traveling, both domestically and internationally. A Bachelor's degree in a scientific field and at least 10 years of experience in GMP quality or manufacturing in a biotechnology or pharmaceutical setting are required.

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