Manager of Supplier Quailty Assurance

Duties Include:

* Interface with Corporate Purchasing Plant Quality Management and R&D Management as well as Critical Suppliers to assure supplier quality assurance program remains incompliance with applicable regulatory/industry regulations, applicable standards and Akorns's internal quality system.
* Serve as the primary Akorn management representative in administering supplier-related investigations root cause analysis, and ensuring corrective/preventive action implementation - for quality-related issues that carry potential impact to Akorn products or processes.
* Maintain the supplier approval process with current status reporting of all approved and pending suppliers.
* Oversee plant based skip lot/ skip attribute and certified supplier programming, on a selective basis, for those raw materials and/or components that qualify for such reduced testing requirements.

Education and Experience:

* Bachelor's Degree in Pharmacy, Chemistry or similar degree required
* 7 years of direct experience in management preferred
* 5 years of experience in supplier qualification/auditing preferred
* Must have an understanding of the regulatory guidelines and/or compliance documents
* Experience managing and trouble-shooting major projects
* Thorough knowledge of applicable FDA/cGMP and ICH guidelines
* Skilled presenter to interface with senior level management

To find out more about Real Staffing please visit www.realstaffing.com