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Director GCP/GVP Quality Systems

  • Job type: Permanent
  • Location: Princeton, New Jersey
  • Salary: US$180000 - US$215000 per year + 20% Target Bonus + Stock + Healthcare
  • Job reference: 358961/007_1567550466
  • Sector: Quality Assurance, EPM Scientific
  • Date posted: 03/09/2019

Director GCP/GVP Quality Systems

Princeton, New Jersey

A rapidly expanding pharma company is seeking a Director GCP/GVP Quality Systems position to join its rapidly expanding team. This company CNS focused company has a rich pipeline of drug candidates as well as a marketed product giving added stability you do not always see in smaller organizations. This organization has hundreds of millions of dollars in revenue all while maintaining a small start-up feel. If interested in learning more, don't hesitate to apply!

The Director GCP/GVP Quality Systems will have the following responsibilities:

  • Direct and maintain the R&D (GCP/GVP) quality system program; promote and facilitate continuous quality improvement.

  • Oversee quality system function(s) including: Deviation Management and CAPA processes within R&D (GCP/GVP). Participate in the development, implementation and management of electronic Quality Management System (QMS) to support R&D operations.

  • Provide to R&D (GCP/GVP) support and guidance for Document Control and Records Management including implementation and management of systems.

  • Oversee R&D R&D (GCP/GVP) Training

  • Ensure a compliant end-to-end process for quality system documentation management within R&D (GCP/GVP).

  • Work with Quality Risk Management and Quality Assurance within R&D (GCP/GVP) Quality Management to monitor performance of the R&D (GCP/GVP) QMS.

  • Develop, implement and manage Inspection Readiness systems and processes.

  • Provide support during regulatory inspections, other external and internal audits.

The ideal candidate will have the following skill set:

  • Bachelor's degree in Life Sciences.

  • A minimum of 10 years' experience in pharmaceutical or biopharmaceutical industry with increased responsibilities related to GCP/GVP Quality.

  • A minimum of 5 years in a leadership role in R&D GCP with SDLC knowledge. Must be knowledgeable in GvP and GLP.

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