Insight Global | Quality Manager

3 days ago

king of prussia, United States Insight Global Full time

One of our pharmaceutical clients is seeking a Quality Manager to join their growing team in King of Prussia, PA. This is a great opportunity to join and advance with an innovative and high-growth global company committed to sustainability. The Quality Manager will oversee the quality control and quality system functions, ensuring compliance with global pharmaceutical regulations and standards, company quality policies, and industrial standards such as ISO 9001. This individual is responsible for all quality control laboratory supervisors, leads and technicians, and will be working cross-functionally with Global Teams and Site Leaders, acting as a bridge between Quality and Production. Other responsibilities include:

  • Accountable for all incoming, in-progress and final product testing and supervises lab instrumentation and calibration schedules
  • Monitor and communicate non-conformances and recommend measures to improve methods and quality of product
  • Develop and implement changes in working conditions and use of equipment to increase efficiency of the department and quality matters
  • Communicate all deviations and non-conformances to plant management, support investigations and work closely with global quality teams
  • Oversee internal audit process and coordinate with authorities and customers for the planning and execution of audits.
  • Develop and maintain site quality metrics and ensures compliance and identification of trends leading to site/process/product improvements.
  • Oversee the process for reviews of completed batch production and laboratory control records of critical process steps before release of the products for distribution
  • Analyze and approve general and operating procedures, work instructions and other quality-related documents
  • Ensure a robust stability program supporting product, raw materials, QC Reagents and sets retest/expiry dates and storage conditions where appropriate


Qualifications:

  • Minimum of a Bachelor’s Degree in a related field
  • 7 years of Pharmaceutical Quality (QA and/or QC) experience
  • 3 years of Supervisory or Management experience
  • Prior experience working in a GMP environment
  • Knowledge of quality assurance requirements for pharmaceuticals: 21 CFR Parts 210/211, ISO 9001 standard requirements


Pay: $60.00-$70.00/hr (can be flexible based on experience)

Hours: Monday-Friday, 8:00am-5:00pm

Hiring Method: 6 month-long contract to permanent full-time hire (performance based)

Benefits: Medical, Dental, Vision and 401K plans available


Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

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