Associate Director, PV Quality Management

5 days ago

Cambridge, Massachusetts, United States BioSpace, Inc. Full time
Job Summary

We are seeking an experienced Associate Director, PV Quality to join our team. This role will provide quality oversight of, and support and guidance to the Moderna pharmacovigilance system and pharmacovigilance activities conducted by Moderna and its service providers.

Key Responsibilities
  • Provide compliance support to the Moderna PV organization
  • Establish and maintain a robust global audit program for PV
  • Assist in managing Regulatory Authority inspections of Moderna's PV system
  • Lead the development of PV Annual Audit Plans
  • Partner with the CSPV, GRS and other functional area organizations to create a quality culture within Moderna
  • Provide support for junior staff members and mentorship within the RDQ PV function
Requirements
  • BS/BA, MS or PhD/PharmD and a minimum of 10, 8, 6 years experience, respectively, in Biotech, Pharma or Clinical Research Organization
  • Audit certification (e.g., ASQ Lead Auditor) preferred
What We Offer
  • Highly competitive and inclusive medical, dental and vision coverage options
  • Flexible Spending Accounts for medical expenses and dependent care expenses
  • Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
  • Family care benefits, including subsidized back-up care options and on-demand tutoring
  • Free premium access to fitness, nutrition, and mindfulness classes
  • Exclusive preferred pricing on Peloton fitness equipment
  • Adoption and family-planning benefits
  • Dedicated care coordination support for our LGBTQ+ community
About Moderna

Moderna is a leading biotechnology company that is pioneering the development of mRNA-based therapeutics and vaccines. We are committed to improving the lives of patients and advancing the field of medicine.

We are proud to be an equal opportunity workplace and are an affirmative action employer. We are committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.

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