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Business Title Director, Quality
Business Global Quality
Sub-Business Medical Products Support
Location of Position Bloomington, IN
Manages the Quality organization in a large size plant performing Contract Manufacturing. Is responsible for results in terms of product quality and conformance to regulations and Baxter policies. Acts as the Management Representative for Quality.
Oversees Quality Control Laboratory Operations including analytical chemistry, microbiology, environmental monitoring, sterility testing and product stability testing.
Oversees Quality Assurance functions including final product release, exception management, product complaint handling, and manufacturing process monitoring activities, internal assessment and annual product review.
Involvement with Quality Agreement development and approval
Manage regulatory inspections and interface with Regulatory agencies
Ensure client requirements are met
Frequent interaction and communication with potential and existing clients
Partner with manufacturing and business leaders to continuously improve processes
Fiscal responsibility for the Quality Department budget
In depth knowledge of the regulatory environment for the manufacture of medical products, specifically aseptically filled and terminally sterilized injectable products.
Knowledge of the Contract Manufacturing business helpful
Strong leadership skills and demonstrated success in managing a large team.
Strong analytical and problem solving skills
Excellent verbal and written communication skills
Success working with multifunctional, global teams.
Excellent interpersonal/communication/influencing/negotiation skills.
BS in science or engineering; advanced degree helpful.
Minimum of 10 years experience in Quality, Manufacturing or related field in the medical products industry.
7 years management experience.
Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)
Doing Work that Matters Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at http://www.careers.baxter.com/. EOE M/F/D/V.