Quality Manager, GMP (s957)

  • Contract Duration: 12+ months, potential to extend
  • Manufacturing
  • Framingham, MA

Website Lenox Executive Search


Lenox Executive Search is seeking to fill a contract role for a Quality Manager with one of our global pharmaceutical clients. The Quality Manager position is a one year contract with possibility of extension.

Core Responsibilitiesof a Quality Manager include:

  • Investigating and writing deviations, laboratory investigations, CAPAs, Tasks, Effectiveness reviews, and audit observation responses.
  • Define and implement CAPAs, tasks, and effectiveness reviews with the assistance of QC Management
  • Manage / own CCRs and liaise with functional QC units for work execution
  • Conduct self-inspection / audit walkthroughs
  • Support internal / external audits and participate in and / or lead the completion of responses to internal / external audit related observations / CAPA
  • Conduct gap assessments against external and / or other Company sites audit observations and assist with plan development to drive remedial actions.
  • Maintain a high level of personal compliance to the required company standards and industry best practices
  • Provide expertise during procedure / SOP revision process and function as DCR approver for department related SOPs, where required
  • Partner with QC operations and manufacturing, where applicable, to support a culture of continuous compliance / improvement
  • Assist in generating metrics at the required frequency to drive accountability and delivery of targets
  • Bachelor’s Degree in science or technical field 6 years’ of experience in biopharmaceuticals or related industry working in a regulated, GMP environment

Or Master’s degree and a minimum of 3 years’ experience working in a regulated, GMP environment.

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