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Manager, Vendor Quality

Princeton, New Jersey
13 Sep 2023

Manager, Vendor Quality

  • Location - NJ based team
  • Position Hybrid
  • 3 months to start-possible extension
  • Pay - market rate
  • 6-8 years' experience
  • Looking for someone who's worked with CSV, GcLP, GCP, GLP space
  • Experienced with following regulation: ICH GCP E6(r2) or FDA Parts 11, 50, 56, 312
  • R&D clinical issue management experience required
  • Clinical Operations and Clinical Quality experience is required


Reporting to the Director of R&D Vendor Quality within Research & Development Quality (RDQ), located at the Client Headquarters in Cambridge, MA, the contingent Manager will (i) Work with the RDQ and stakeholders to provide Quality support for Client's R&D Quality vendor program and drive continuous improvement of clinical, non-clinical and pharmacovigilance services to the Client 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 Client.


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


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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  • Job Reference: 1112392892-2
  • Date Posted: 13 September 2023
  • Recruiter: Beacon Hill Staffing Group
  • Location: Princeton, New Jersey
  • Salary: On Application