Support strategic initiatives by leading projects to design and deploy process and technology related improvements and monitoring of R&D vendor issues for trends across the operational areas Develop and write vendor issue procedures
Support in developing establishing metrics and KPIs for R&D vendor issues
Define and develop quality agreement process with R&D vendors
Process vendor requests
Quality checks of vendor quality documents
May participate in GCP, GLP, or GVP audits
Requirements:
BS/BA in life sciences and a minimum of 6-8 experience in Biotech, Pharma or Vaccine Industry
Working knowledge of relevant FDA, EU, ICH GCP guidelines, and applicable international GCP regulations, guidelines and local legislation
Auditing experience in GCP, GLP, or GVP preferred
Excellent communication skills
Strong interpersonal skills and ability to effectively interact with all levels with the organization
Ability to work independently and within a team environment
Ability to manage multiple projects in a fast-paced environment
Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
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