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Director, Quality - QMR Bloomington

Req #: 170007GU_en
Location: Bloomington, IN US
Job Category: Quality
Date Posted: 10/5/2017 3:19:33 PM
Baxter International

Director, Quality - QMR

Baxter International Inc.

Bloomington, Indiana

 

About Baxter
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services.

The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries.

Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

Position Overview

The Director, Quality - QMR will serve as the Quality Management Representative for the Bloomington, Indiana plant.

 

Essential Duties and Responsibilities:
  • Manages the Quality organization in a large size plant performing Contract Manufacturing. 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.
  • Responsible for developing talent of the team members.

Qualifications:

  • 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.
  • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.).

Education and Experience:

  • 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.

 

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Equal Employment Opportunity  

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.  

EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy

Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an email to Corporate_Staffing_Deerfield@baxter.com or call 877-229-4748 (877-BaxHR4U) and let us know the nature of your request along with your contact information.


 


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