Manager/Senior Manager, Quality Assurance

Job Locations US-Princeton
Posted Date 1 week ago(3/9/2018 3:09 PM)
# of Openings


Manages the supplier qualification program to include external audit program, maintenance of Approved Supplier List, supplier metrics and relationships. Work within the realms of GMP systems to facilitate batch release, change control, and deviation, particularly as they relate to vendor management.  Support on-site clinical manufacturing activities to support all incoming component and material release ensuring complaint, robust and consistent manufacturing, testing and clinical development processes are established and maintained.




Supplier Qualification:

  • Manage the supplier qualification program.
  • Audit key vendors through on-site visits or audit questionnaires.
  • Implement and maintain the site Approved Supplier List
  • Maintain meaningful KPI’s to ensure vendors and CMO’s remain in a state of compliance.
  • Develop and maintain the Supplier Corrective Action program
  • Facilitate sample transfers to 3rd party testing laboratories facilitate vendor qualification.

Internal Audit Program:

  • Participate in performing internal audits of operational functions within the company
  • Help maintain the company maintain a state of audit readiness.
  • Develop audit reports and checklists to ensure compliance at the site.

Sample Management:

  • Manage the incoming receipt program pertaining to raw materials, reagents and components.
  • Coordinate sample transfers to testing laboratories for incoming reagents, in-process materials, finished drug product and stability samples. 


Identify process improvement initiatives and quality measurement tools to monitor and improve quality and technical operations.  Implement appropriate process improvement initiatives throughout the development programs and supply chain including the evaluation of the success of the initiatives.

Evaluate impending regulations, guidelines and industry standards and their impact on the company and contract operations, Provide expertise and training to other departments in support of these standards and guidelines.


Responsible for the technical writing and approval SOP’s, protocols, reports, specifications and other GMP documentation as needed to ensure robust and sustainable quality systems are in place.



  • A minimum of seven years pharmaceutical experience with at least five years of experience in Quality or Regulatory Compliance Operations in the pharmaceutical industry in a decision-making capacity.
  • Knowledge and understanding of the clinical development lifecycle.
  • In depth knowledge of GXP quality systems required for development and commercial biopharmaceutical organizations.  
  • Experience in supporting quality and compliance for Phase I-III clinical and commercial operations.
  • Experience working with third party contract research, development, manufacturing and/or testing organizations.
  • Particularly experienced with resolving complex quality and CMO issues, as well as corrective and preventive actions identification to resolve non-conformances/trends.
  • Standard operating procedures along with controlled changes updates and implementation of actions driving Quality Management System compliance with regulations.


  • Bachelor’s degree in a scientific discipline required.
  • Advanced degree in a scientific or management discipline preferred.


  • ASQ, ACRP, Audit, or RAPS certification preferred.


  • Ability to be on call before and after core business hours.
  • Ability to travel domestic and internationally ≤ 20%.



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