Director of Quality Operations

4 days ago


Cambridge, Massachusetts, United States Meet Full time

Job Title: Associate Director, Quality Operations

Job Summary:

We are seeking an experienced Associate Director, Quality Operations to oversee commercial product distribution and maintain Good Distribution Practices (GDP) for our US affiliate. This role will manage third-party logistics providers, handle product release for distribution, and ensure compliance with GDP regulations and internal quality standards.

Key Responsibilities:

  • Manage day-to-day operations of third-party logistics providers and oversee product release for distribution.
  • Maintain relationships with manufacturing and distribution channels.
  • Handle temperature excursions, product replacement requests, serialization issues, and logistics complaints.
  • Develop and maintain Quality Technical Agreements and oversee temperature-controlled shipping qualifications.
  • Own the Vendor Management and external audit program, ensuring GDP compliance.
  • Manage deviations, CAPAs, and change controls related to GDP.
  • Update annual GDP training materials and maintain training records.
  • Track and report on GDP-related KPIs and metrics.

Requirements:

  • Bachelor's degree or higher, preferably in a science-related field.
  • 12+ years of experience in Quality, with oversight of GDP and third-party logistics in a pharmaceutical or similar environment.
  • Experience with SAP and electronic quality management systems preferred.

This role offers the opportunity to lead quality operations and ensure compliance with GDP standards for commercial drug distribution.



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