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Manager, Vendor Quality

Cambridge, MA 02139

Posted: 01/31/2023 Employment Type: Contract Job Category: Quality and Compliance Job Number: 538706 Pay Rate: 70.00 Is job remote?: Yes Country: United States

Job Description

The Role:

Reporting to the Director of R&D Vendor Quality within Research & Development Quality (RDQ), located in Cambridge, MA, the contingent Manager will (i) Work with the RDQ and stakeholders to provide Quality support for the R&D Quality vendor program and drive continuous improvement of clinical, non-clinical and pharmacovigilance services to the R&D organization. You will work with internal business partners and alignment with business expectations, GxP standards and other applicable regulatory requirements. The Manager will also partner with R&D to create a quality culture within the company.


Here’s What You’ll Do:
  • 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
  • Here’s What You’ll Bring to the Table:
  • 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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