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Head of Regulatory

1 month ago

Round Lake IL, United States BAXTER Full time

At Baxter, we are deeply connected by our mission. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Manage and coordinate routine activities and projects for an individual cell within the Manufacturing Quality Assurance team. This will include such activities as batch review and release, systems release, and nonconformance and CA/PA management while assuring compliance with established standards, regulations, specifications, and SOPs. Ensure that in process materials, finished products, packaging operations, and batch record documentation is in compliance with internal corporate/division/plant quality control programs, current Good Manufacturing Practices, current Good Documentation Practices, and external regulations. Assure the safety and quality of the products, processes, and systems. NOTE: This is a night shift position Monday through Friday. Will interact with manufacturing and supervision daily to address quality process or batch related concerns.

* Performs process compliance audits of all manufacturing areas to assure quality of product/process is achieved.
* Develops, assigns and implements systems, procedures and policies to assure compliance with cGMP's and FDA regulations and company policies and procedures. Assess all plant systems, operations, products, processes, procedures, and documentation for adequacy and efficiency to ensure Quality and Regulatory Compliance related to CA/PA.
* Must have experience with Root Cause Analysis tools and the ability to apply tools to plant scenarios.
* Is responsible for results in terms of timeliness and conformance to regulations and Baxter quality policies.
* Handles documentation and data requests from Pharma clients, division, and product development and support functions related to Quality Management and batch release.
* Maintain appropriate quality metrics for trend analysis and Management Review.
* Balance multiple tasks and projects simultaneously.
* Over see the control and storage of released printed materials and retention samples.
* Bachelor's degree required, preferably in engineering or science and 3-5 years experience in Quality, Manufacturing/related field OR Associate's degree/High School Diploma and 10+ years experience.
* We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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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