Intertwined

GMP Quality Systems Manager (re-lo to Allentown PA area)

Full Time
Baltimore, MD, USA
Description

*Strong relocation assistance provided!


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.


Responsibilities

  • 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.

Requirements
  • 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 mschroeder@thedenzelgroup.com


#IND1


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

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