Associate Director, PV Quality

4 weeks ago

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

We are seeking a highly skilled Associate Director, PV Quality to join our team. The successful candidate will provide quality oversight of, and support and guidance to the Moderna pharmacovigilance system and pharmacovigilance activities conducted by Moderna and its service providers.

The Associate Director, PV Quality will lead the development of PV Annual Audit Plans and partner with the CSPV, GRS, and other functional area organizations to create a quality culture within Moderna and drive toward a sustained state of inspection readiness.

This leadership role will provide support for junior staff members and mentorship within the RDQ PV function.

The Associate Director, PV Quality plays a key role in promoting a quality culture that ensures sustained compliance to global, national, and local regulations.

Key Responsibilities
  • Participate in the development of quality and compliance strategies for the support of global pharmacovigilance activities.
  • Work closely with the Moderna Global Pharmacovigilance and R&D Quality & Compliance (RDQ&C) Process Excellence and Training to support development of R&D policies and procedures related to PV activities.
  • Partner closely with members of Global Pharmacovigilance and the QPPV to support the successful and compliant execution of Moderna PV activities.
  • Conduct and report audits of Moderna's Pharmacovigilance System, including but not limited to audits of PV processes, systems, vendors, and affiliates.
  • Follow-up on CAPAs resulting from audit findings identified during PV audits to ensure effective remediation.
  • Develop and maintain Annual Audit Plans for the RDQ&C GVP audit program.
  • Provide input into the issue management program to ensure early detection of issues, development of appropriate and robust corrective and preventative actions (CAPA), tracking of CAPA completion, and assessment of effectiveness is attained.
  • Actively participate as a key member of the inspection team for inspections of Moderna's pharmacovigilance system, including RDQ Inspection Host and participate, as needed, in PV Regulatory Authority inspections.
  • Provide strategic input in the development of responses to Regulatory Authority inspection findings for inspections of Moderna's PV system.
  • Participate in Regulatory Authority inspection and provide input and review of responses to inspection observations and regulatory agency questions resulting from inspections.
  • Contribute to the continuing development of a quality culture at Moderna.
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.
  • This role is based in our new LEED-certified HQ in Cambridge, MA, and is expected to be in office 70% of the time with flexibility to work from home up to 30%.

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