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Summary

This role serves as the Product Quality technical expert for product life cycle activities within the Pharmaceuticals Global Business Unit (GBU). Product areas include inhaled anesthetic gases and generic injectables. Has overall responsibility for results in terms of product quality and conformance to regulations and Baxter quality policies.

Essential Duties and Responsibilities.

• With minimal guidance, serve as the technical expert within a department in the Quality organization with responsibility for results in terms of product quality, performance and safety. 
• Implements the quality systems procedures and manages compliance in a section or department. Ensures compliance with quality systems and regulatory requirements (Change Control, NCR, CAPA, Design Control, Investigations, etc.) to assure product quality.
• Understands and assures conformance to regulations in a section or department. May interfaces with regulators during regulatory inspections and/or provide support to the Baxter site during regulatory inspections.
• Executes and/or oversees the process for product complaints, including evaluations, escalations, trending, collaboration with manufacturing plants, review and/or approval, etc.
• Conducts monthly Product Quality Data Review meetings.
• May participate in or manage quality assessments of internal operations and suppliers to analyze compliance and assess risk.
• Interacts frequently with leaders and functional peer group of technical experts.
• Identifies and leads continuous improvement projects with the objective of achieving quality, reliability and cost improvements.

Qualifications. 

• Thorough knowledge of applicable procedures, specifications, regulations and standards.
• Effectively operate in and facilitate cross-functional teams with minimal guidance.
• Must be able to provide solutions that reflect understanding business objectives, cost implications, and engineering challenges.
• Strong analytical and problem-solving skills, including dealing with ambiguity.
• Good communication and leadership skills.
• Good interpersonal/communication/influencing/negotiation skills.
• Good project management skills.
• Occasional travel required (5%-10%).

Education and/or Experience. 

• B.S. degree in science or engineering.
• 5-8 years experience in Quality, Manufacturing, Engineering, Technical or related field.

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.
                                                                                                                                                               
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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 e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.