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Senior Manager of Clinical Quality Assurance

2 months ago

Cambridge, Massachusetts, United States Moderna Therapeutics Full time
About the Role

The Senior Manager of Clinical Quality Assurance will play a critical role in promoting compliance to Good Clinical Practice (GCP) regulations by providing Clinical and Research Development teams with compliance guidance and support related to GCP global regulations and guidelines.

Key Responsibilities
  • Develop and implement clinical quality assurance strategies to support global clinical trials
  • Partner closely with members of the Clinical and Research Development groups to ensure the successful and compliant execution of clinical trials
  • Provide proactive guidance to complex issues and identify and report systematic issues and areas for improvement
  • Participate in regulatory authority inspections and serve as a trainer and mentor to auditor trainees
  • Contribute to the continuing development of a quality culture at Moderna
Requirements
  • BS/BA, or MS and a minimum of 10 or 5 years experience, respectively, in Biotech, Pharma, Medical Device, or Clinical Research Organization
  • Working knowledge of relevant Good Clinical Practices (GCP) and applicable regulations/guidelines
  • Experience working with CROs, vendors, and relationship management preferred
  • Prior experience managing individuals preferred
About Moderna

Moderna is a leading biotechnology company that is committed to changing the future of medicine. We are proud to be an equal opportunity workplace and are an affirmative action employer.

We are focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.