Intertwined

GMP Manufacturing Compliance Manager

Full Time
Rollins Park, MD, USA
Description

The Denzel Group, an award-winning search firm, has been chosen to work with a Global Pharma leader in Rockville on their quest for a talented GMP Manufacturing Compliance Manager. In this role you will work cross-functionally to write/close deviations and support CAPAs, as well as support change control and manage batch production records. Your strong leadership in this position will help to ensure compliance with SOPs, and ultimately GMP standards.


Responsibilities 

  • Team leadership: hiring, training, performance management, etc.

  • Author, review and approve production deviations, change controls, and CAPAs.

  • Write production investigations.

  • Process improvements: Drive the continuous reduction of deviations by implementing preventative actions.

  • Perform real-time batch record reviews.

  • Track and trend all data relevant to the deviation/CAPA/change control/batch production records.

  • Act as the SME for defending deviations in GMP audits.

Requirements
  • Relevant BS Degree.

  • 5+ years of GMP pharma technical writing experience, relating to manufacturing deviations.

  • Strong GMP production experience regarding troubleshooting, investigation, root cause analysis, and continuous improvement.

  • Supervisor experience with direct reports.



GMP, manager, supervisor, deviation, investigation, technical writing

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