Clinical Quality Assurance Manager

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Rye, NY

Industry: Pharmaceuticals & Biotech

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Not Specified years

Posted 7 days ago

This job is no longer available.

This is an exciting opportunity to join our client, an established large-size pharmaceutical company who has 8+ approved products on the market. This is a permanent, long-term stable position which will offer you the opportunity to advance internally as they look to expand their product pipeline!

In this role you will be responsible for planning and performing clinical vendor audits (of CROs, laboratories, etc.) in accordance to the objectives set prior to the fiscal year. These types of audits are necessary based on the ICH & GCP Guideline which requires oversight by the study sponsor of trial-related functions carried out on its behalf, as well as being a regulatory expectation and a good business practice. The position conducts internal system/process audits as well as data integrity audits as directed.

Responsibilities:

  • Execute audits of clinical vendors used in clinical research, including the drafting of Audit Plans, Audit Agendas, Initial and Final Audit Reports, and Audit Certificates. Track unresolved CAPAs until completion.
  • Execute audits of internal system/process audits and data integrity audits, including the drafting of Audit Plans, Initial and Final Audit Reports, and Audit Certificates. Track unresolved CAPAs until completion

Salary

$110K - $130K