Director of Quality Operations
4 weeks ago
Job Title: Director of Quality Operations
Summary:
The Director of Quality Operations is responsible for overseeing commercial product distribution and maintaining Good Distribution Practices (GDP) for the US affiliate. This role manages third-party logistics providers, handles product release for distribution, and ensures compliance with GDP regulations and internal quality standards. Reporting to the Senior Director, this position collaborates with internal teams and manages vendor relationships to support the successful distribution of commercial drug products.
Key Responsibilities:
- Oversee day-to-day operations of third-party logistics providers and manage 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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