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Pharmaceuticals Manufacturing: Director of Quality

Central New Jersey

Our Central New Jersey operating company has just celebrated its 10th consecutive year of double digit growth. This continued growth has resulted in the addition of new production lines and product capabilities, creating a role for a new Director of Quality (as the incumbent takes on additional responsibilities).

This role will oversee a department of 75 people, managing the regulatory, validation and quality functions in support of manufacturing operations. Additional, responsibilities include the authorization and implementation of plant-wide policies (SOPs) assuring compliance with corporate and government regulations.

Areas of management responsibilities will include Site Regulatory Compliance, Raw Materials and Finished Product testing (chemical and microbiology, physical, etc.), Validation of Test Methods and Manufacturing Processes as well as budget responsibility and customer interface.

This is a highly visible role in a growing organization offering senior site strategic responsibilities.

Persons with wide-ranging QA/QC managerial skills, including laboratory management, and a minimum of 15 years of experience and hands on work may qualify. This experience should encompass OTC and Rx Pharmaceuticals, including NDA filed products. Sterile and aseptic processing experience is a plus. Thorough knowledge of FDA regulations and involvement in establishing plant-wide quality systems also required. Communication skills and the ability to interact with customers and colleagues at all levels is required.