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Sr. Pharmaceutical Quality Leader

Req #: 180004XF_en
Location: Round Lake, IL US
Job Category: Quality
Date Posted: 3/1/2018 8:29:16 PM
Baxter International


This person will be the primary Quality contact for the development and deployment of projects for new pharmaceutical products. He/she will act as the aseptic subject matter expert for Quality and ensure programs are executing to the intent of the Quality System procedures and regulations.  This position will be interacting with R&D, Operations, and other support functions to ensure the products and equipment being created provide safe and effective products for the market.
Essential Duties and Responsibilities:
  • Support projects by ensuring team understand and execute the aseptic Quality requirements necessary for the products being consider.   
  • Understands and assures conformance to regulations (21 CFR 210/211, EU Directives, MHRA “Orange Guide”, and ICH Guidelines)
  • Provide support for plant audits, due diligence, and supplier audits when needed
  • Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvements
  • Devises new approaches to complex problems through adaptations and modifications of standard technical principles
  • Thorough knowledge of applicable procedures, specifications, regulations and standards, as well as a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise
  • Ensure 3rd party service providers understand intent and regulations necessary for product quality and safety.
  • Actively lead in Make vs Buy and plant transfers of products in the pharmaceutical business.
  • Act as in-house global expert for Production & Process Controls for Pharmaceutical facilities
  • Collaborate and ensure understanding of Validation requirements for new products and changes to existing products



Qualifications for this role:
  • Deep understanding and direct knowledge of terminal and aseptic operations
  • Strong understanding of Production and Process Controls in operations
  • Prior experience managing teams in Quality Operations
  • Previous experience launching new pharmaceutical products to market
  • Understanding of global regulations for pharmaceutical and biologic products
  • Strong leadership skills and ability to manage/supervise a large team of employees
  • Ability to engage management and other functions to influence decisions on courses of action
  • Must have excellent project management skills and the ability to influence others
  • Strong analytical and problem solving skills
  • Strong verbal and written communication skills
  • Must be able to provide solutions that reflect understanding business objectives, cost implications, and engineering challenges
  • Willingness to travel up to 25% domestic and international
Education and Experience
  • BS in Pharmacy, Chemistry, Microbiology or Engineering: advanced degree helpful
  • 7 years in Quality, Manufacturing, Engineering or related field in pharmaceutical and/or Biologics manufacturing site.
  • Previous Project Management and/or experience launching aseptic and/or biologic products
  • Previous auditing experience is preferred
  • Previous contract manufacturing experience preferred

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

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