Director of R&D GCP Compliance
Real - Cambridge, MA

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There is a great opportunity for a Director level position in a Clinical R&D Compliance role for a biotechnology company inCambridge,MA. The Director of Clinical R&D Compliance will be working cross functionally with the auditing team, GLP team, and with the GCP team. This position will allow you to manage others while having an individual contributor role.

Key Responsibilities Include:
  • Managing and setting up auditing sites to ensure auditing standards are upheld against company policies and procedures
  • Performing audits of internal and external vendors
  • Planning and executing internal audits for cross functional units within the Quality groups
  • Managing vendors and CMOs during external and internal auditing
Key Requirements Include

  • Excellent previous direct GCP experience in a pharmaceutical or biotechnology firm
  • BS Degree in a scientific or health related field
  • Previous management experience in an auditing or Quality Assurance role
  • Previous GMP or GLP experience preferred but not required
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