Job Description:

Location: Morristown, NJ

Salary: TBD

Description: Our client is currently seeking a QA Manager Operations who can provides quality and compliance oversight of third party contractors and external partners for company for distribution in the U. S. market.


This job will have the following responsibilities:



1. Handles day-to-day Quality responsibilities for assigned products manufactured by Third party suppliers and distributed by company in the US


2. Performs batch record review and release for Third party manufactured products


3. Reviews and approves Deviations, Investigations and Change Controls associated with Third party manufactured products


4. Reviews and ensures that Annual Product Reviews, Stability Management, and Retain / Reserve Sample management systems are in compliance for Third Party manufactured products


5. Tracks metrics for external businesses partners/CMOs on change controls, deviations, complaints, audits, product releases and rejections and other Third party QA KPIs (Key Performance Indicator).
Qualifications & Requirements:

Bachelor's degree in Chemistry, General Biological/Physical Science or related science from an accredited college or university with a minimum of 10 years of experience in Quality in the pharmaceutical industry.

Must have previous experience with Third party / supplier Quality.

Generic pharmaceutical industry experience is preferred.

Contact: arawat@judge.com


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