Aseptic Pharmaceutical Operations Manager

4 days ago


Lakewood, New Jersey, United States GQR Full time

Description:

GQR is hiring an Aseptic Pharmaceutical Operations Manager to oversee equipment, critical utilities, and facilities validation activities in support of commercial and new R&D drug product development activities.

This position offers a competitive salary of $115,000 to $130,000 depending on experience.

The successful candidate will be responsible for supervising direct reports, carrying out team lead/team oversight responsibilities in accordance with the organization's policies, and ensuring compliance with FDA, ISO, EMA, and any other applicable domestic and international regulations.

A Bachelor's degree in a Science, Engineering, or related field is required, along with minimum five years' relevant experience performing validation activities within an aseptic pharmaceutical environment.

  • Overseeing the overall qualification activities related to the support activities or prerequisites to Process Performance Qualifications (PPQs, otherwise known as Process Validation).
  • Providing internal and external customer feedback, ensuring on-time delivery of milestone activities, project staffing, and overall supervision of direct reports.


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