QMS Manager

Location: Boston, MA
Department: Azzur Consulting LLC

Job Description

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success. We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:

Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!

The QA/QC Manager will be responsible for developing and ensuring that the quality management
system (QMS) is fully implemented in an organized and efficient manner. 

Duties and Responsibilities
  • Develop and implement the Quality Management System, including: Project planning, scheduling, and execution.
  • Streamlining operations through process improvements, identification of synergies, and evaluation of internal controls and deployment of tools/systems.
  • Provide leadership and mentorship to all personnel.
  • Take responsibility for hold-point releases once all QMS functions have been completed
  • Manage project quality to ensure compliance to codes, standards, regulations, equipment specific specifications, and QMS requirements.
  • Develop risk-based inspection (RBI) activities and processes, and develop internal standard practices.
  • Compliance and quality resolution through CAPAs
  • Mitigation planning
  • Qualification and validation of: analytical test methods, instrumentation, laboratory equipment, computer systems, facilities, etc.
  • Develop and manage non-conformance, deficiencies, and reporting programs, including root cause analyses.
  • Interface with auditors from clients and regulatory agencies.
  • Guide and train QA/QC personnel
  • Monitor project QA/QC budgets
Required Qualifications
  • Bachelor's degree or Master's degree in Biotechnology or related field within science/engineering
  • 10 years' relevant experience in quality systems, especially in a supervisory or management capacity

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