Associate Director, RD Quality

Company: Moderna
Location: Cambridge
Posted on: November 23, 2020

Job Description:

The_Role Moderna is seeking an Associate Director, R&D Quality, reporting to the Vice President of R&D Quality. This person will be responsible for the design, development and implementation of a Quality Management System (QMS) for Research & Development (R&D). The individual will primarily work with the R&D organization (e.g., Clinical Development Organization (CDO), Safety, Non- Clinical, etc.) and R&D Quality colleagues to ensure development of a QMS that is fit for purpose for R&D including all applicable elements of a QMS (i.e., Policies & Procedures, Knowledge Management, Issue Management, etc.). This individual will also be responsible for conducting periodic assessments of the R&D QMS to facilitate continuous improvement and to maintain an awareness of the health of the QMS. This individual will support the R&D QMS and drive continuous improvement of clinical, pre-clinical and pharmacovigilance services to the Moderna R&D organization. Works on assignments requiring considerable judgement and initiative. Understands implications of work and makes recommendations for solutions. The successful candidate must have experience in a biotech or pharmaceutical GCP, GLP and/or GVP environment. Here s_What_You ll_Do * Execute and/or oversee assessment of the R&D QMS * Partner with R&D functions (e.g., Clinical Development, Safety and Non- Clinical) to collaborate * Aide in the establishment and maintenance of R&D policies and procedures * Review, approve, maintain procedural documents (e.g., policies, procedures, etc.) * Track procedural documents for periodic review/revision to ensure continued applicability to Moderna practices *

Keywords: Moderna, Cambridge , Associate Director, RD Quality, Executive , Cambridge, Massachusetts