Assistant Director of Quality - (US-NJ-Paterson - 07544)

Minimum Education: Bachelors
Job Type: Full Time
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Our privately held pharmaceutical client is looking for an Asst. Director of Quality. This position is primarily responsible for the Quality oversight of all External Manufacturing and Packaging contractors utilized by the company. This position encompasses all quality activities associated with External Manufacturing and Packaging contractors/vendors as they relate to investigations, batch release, product complaints, routine processing, protocols, artwork approval, change controls, APRs, Quality Standards and stability. Specific job responsibilities include the following: * Manage a small staff of QA professionals * Maintain effective guidance and support to the External Manufacturing and Packaging contractors * Work with internal departments to identify business opportunities and ensure infrastructure is in place for each third party to produce or introduce compliant product and/or service * Track and Trend QA metrics (Complaints, Investigations, CAPAs) * Approve all applicable standards and specifications, protocols as they relate to External Manufacturing and Packaging contractors. A minimum of ten years of pharmaceutical or related Technical Operations/Quality experience. A minimum of two years should have been spent directly in Quality Assurance and at least two years working with third party suppliers. A minimum of a B.S. in Science/Engineering discipline is required. They are looking for someone with Rx experience



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