Associate Director, Quality Operations
8 hours ago
US Tech Solutions is seeking an experienced Associate Director, Quality Operations to join our team. In this role, you will be responsible for ensuring the quality and compliance of our commercial drug distribution operations.
Key Responsibilities:- Manage third-party logistics service provider operations involved in commercial drug distribution.
- Release commercial batches to trade and for shipment to other markets, including review of shipping records and temperature traces.
- Establish and maintain relationships with manufacturing and distribution channels.
- Review and respond to temperature excursions, product replacement requests, serialization issues, and logistics complaints.
- Develop and maintain Quality Technical Agreements.
- Quality oversight of temperature-controlled shipper qualifications.
- Ownership of local Vendor Management and external audit program.
- Communication, initiation, and management of any GDP related Deviations, CAPAs and change controls.
- Review and update Annual GDP training materials.
- Maintain and report on KPI metrics.
- Minimum 12+ years of experience in Quality responsible for oversight of Good Distribution Practices and third-party logistics in a pharmaceutical or similar setting.
- SAP experience is preferred.
- Experience with electronic platforms for quality systems management and training.
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. We are an Equal Opportunity Employer and welcome applications from qualified candidates without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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