Quality Manager - Job ID:4495

Responsibilities:

  • Host partner audits and regulatory agency inspections.
  • Act as Change Control Manager/Coordinator and subject matter expert, facilitate all change control meetings and activities, and assure change control activities are performed in a compliant, timely and contentious manner.
  • Act as Deviation/Event process subject matter expert and facilitate deviation/event management.
  • Coordinate completion of Annual Product Quality Reviews (APQRs) by facilitating consolidation/summarization of internal and contractor data.  Assure timely completion and communication in alignment with Cubist procedures and Quality Agreements.
  • Coordinate Technical Quality Agreement completion by facilitating meetings with internal and external stakeholders in alignment with Cubist Quality policies and procedures. 
  • Act as Product Complaint Manager/Coordinator and subject matter expert, facilitate all Complaint Review Board Meeting meetings and activities, and assure activities are performed in a compliant, timely and contentious manner.
  • Introduce new and innovative approaches to continually improve our quality systems and practices.
  • Monitor quality metrics.  Troubleshoot issues and support metrics improvements related to Change Control, Deviations/Events/CAPAs, and APQRs.
  • Participate in or lead Quality System improvement project teams as required.
  • Improve and manage the corrective action / preventive action (CAPA) process and systems to assure elimination of root causes and timely response to identified issues.

 Qualifications:

 

  • Bachelor's degree and 9 + years of cross functional responsibility in Quality Systems.
  • Demonstrated ability to work efficiently under conditions of multiple deadlines and changing priorities.
  • Excellent understanding of pharmaceutical regulations.
  • Proficiency with MS Office and software programs for generating reports, presentations and statistics
  • Proficiency with TrackWise. 
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