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Quality Systems Manager, Hosting 13485 Audits (Allentown PA)

Full Time
Edison, NJ, USA

This role is on-site 4 days/week in Allentown, PA. Strong relocation assistance to be provided!

Must have strong experience hosing 13485 Audits and FDA Inspections (either CDRH or CDER)

The Denzel Group, an award-winning search firm, has been chosen to work with a global industry leader with locations in the Lehigh Valley on their quest for a talented Quality Systems Manager. In this role you will be overseeing 29 people, with 8 direct reports. This is a high impact role as the final decision maker on quality related aspects.


  • Establish and maintain 8 quality management systems (CAPAs, internal audits, batch release, change control, etc.) compliant with GMP and company SOPs.

  • Oversees audit programs for suppliers, and internal / external audits.

  • continuous improvement of Quality Management System.

  • Plans and execute Customer and/or Third party Audits.

  • Team management: hiring, performance management, termination, scheduling, budgeting, etc.

  • Determines best course of action for day to day aspects and issues such as recalls, what product can be released, maintenance of quality metrics.

  • BS degree, at minimum.

  • 7+ years’ quality experience in a GMP manufacturing environment, including audits, inspections, and medical device regulations such as 21 CFR 820 and/or 13485.

  • Management level experience (Manager title) in a GMP quality environment.

  • Regulatory audit experience, including face to face involvement answering questions from regulatory agents.

To apply please send your application to


quality, GMP, FDA, 21 CFR 820, 1345, audit, inspection, SOP, manager.

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