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. 

Candidates must live local and be a US Citizen or Green Card Holder

 

Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc.

www.cwsciences.com

 

 

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