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Quality Assurance Manager

  • LocationDurham, NC 27703 - United States
  • Work TypeFull time
  • Positions1 Position
  • Published At:a month ago
  • Job no: 42409
  • Category: Quality

Job Description


Our client, a leading pharmaceutical company, is currently seeking an accomplished Quality Assurance Manager to join the team. Here is an overview of the role:


1) Establish and manage quality controls and processes for the company to partner with internal and external supply sites to ensure product compliance

2) Identify gaps in the company’s quality process and develop and maintain relevant SOPs and ensure adherence as relevant

3) Prepare quality agreements with third-party suppliers to manage third-party quality performance and check their quality compliance and systems are adequate

4) Interface with the company’s Supply Chain Team and the supply sites for all quality matters

5) Review, monitor and quality release functions for third-party commercial releases, which includes review of change controls, deviations, OOSs and commercial batch records

6) Ensure that third parties develop and track CAPAs against deviations and OOSs for timely closure of the actions

7) Assist and coordinate quarantine release functions for company products

8) Assist and coordinate information collection from Quality and R&D teams for RFP questions from the Sales Team

9) Manage quality and service agreements with distributors and service providers/REMS programs

10) Develop quality performance metrics with third parties and review progress at regular meetings


Critical Requirements


1) Appropriate full-time work experience is mandatory (no students or fresh graduates please)

2) Recent experience in the pharmaceutical industry is strongly preferred

3) Preference will be given to candidates with recent experience in quality assurance management


This role is a great opportunity for the right person looking to advance their career with a wonderful company. If you are qualified and think that you are a strong fit for this role, please apply ASAP!


Compensation and Other Details


Base Salary: Highly competitive package, commensurate with experience





  • Published on 18 Aug 2022, 12:42 PM