International Quality Director, Pharmaceutical Manufacturing
St. Louis, MO

Industry leading, global pharmaceutical company seeks a Quality Director to lead international corporate quality strategy and systems, supporting off shore operations including Asia, Latin America, Canada and EMEA. The International Quality Director will develop and drive cGMP quality strategies including product issues and field actions. Additional responsibilities will include:

Work with international regulatory agencies and regional company personnel in managing product quality and regulatory compliance matters specific to individual countries
Oversee international cGMP compliance
Develop strategic quality direction, defining key plan elements; integrate goals and objectives into short and long term plans
Develop communications plans for international problem resolution

Job Requirements

Bachelor's degree in engineering or physical science; advanced degree preferred
10+ years experience in quality in the development and manufacture of pharmaceuticals; experience should include a variety of dosage forms, bulk, sterile - liquid, solid dosage
A strong background in the interpretation of international pharmaceutical regulations and standards and the ability to apply a range of situational issues to achieve compliance
Strong negotiating skills and the ability to defend quality systems, quality control and distribution internationally
Excellent working knowledge of the nuances of various international pharmaceutic regulatory agencies
Strong problem solving skills and the ability to act decisively under complex constraints and tight deadlines

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