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Clinical Quality Assurance Senior Manager

2 months ago

Cambridge, Massachusetts, United States Moderna Therapeutics Full time

Senior Manager of Clinical Quality Assurance

  • Champion adherence to Good Clinical Practice (GCP) standards
  • Offer expert guidance on global GCP regulations
  • Utilize GCP knowledge to enhance the auditing framework
  • Collaborate with study teams to foster a culture of quality within the organization

Core Responsibilities:

  • Engage in the formulation of clinical quality assurance strategies
  • Work alongside Clinical and Research Development teams to ensure effective clinical trial execution
  • Deliver proactive support to study teams on intricate challenges
  • Develop and uphold audit strategies
  • Organize, conduct, and document GCP audits
  • Detect systemic issues and propose areas for enhancement
  • Participate in inspections by regulatory authorities
  • Act as a mentor and trainer for auditor trainees
  • Support the cultivation of a quality-centric culture

Essential Qualifications:

  • Bachelor's or Master's degree with relevant experience in Biotech, Pharmaceuticals, or Clinical Research Organizations
  • In-depth understanding of GCP regulations and guidelines
  • Experience collaborating with Contract Research Organizations (CROs) and vendors
  • Exceptional auditing capabilities
  • Strong communication and presentation skills

About Moderna:

Moderna Therapeutics is at the forefront of mRNA technology, dedicated to transforming the landscape of medicine. Join us in our mission to create a future where every interaction is an opportunity for growth, contribution, and significant impact.