Director, Product Quality Systems
Director, Product Quality Systems
Baxter International Inc.
Location - Round Lake, Illinois
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 is located in Round Lake, Illinois.
- Act as a strategic partner to R&D & Manufacturing to help ensure QS elements are appropriate for use
- Product Quality Systems expert (Design Control, Change Management, Risk Management, and Post-Market Trending)
- Ensure current Quality Systems are meeting industry regulations
- Responsible for results in terms of product quality and conformance to regulations and Baxter policies
- Manage, identify, hire, develop and recognize staff globally (US and EU)
- Identify potential resource needs and need for funds to support job responsibilities
- Provide guidance to the team on creation and maintenance product Design History Files and Risk Management Files according to relevant regulatory requirements
- Provide leadership in the creation and prioritization Product Quality Systems activities
- Accountable to drive consistent project management practices across Product Quality Systems organization
- Strong leadership skills and demonstrated success in managing a large team; ability to manage remotely located staff members
- In depth knowledge of the regulatory environment for the manufacture and development of medical products
- Strong analytical and problem solving skills
- Excellent interpersonal/communication/influencing/negotiation skills required
- Knowledge of GMPs, FDA guidelines, ISO standards and all applicable regulations that ensure product quality and safety.
- Capable of analyzing and solving complex problems through innovative thought and experience
- Must be able to communicate with multifunctional groups at all levels of management
- Willingness to travel up to 30% domestic and international
- BS in science or engineering; advanced degree helpful
- Minimum 10 years relevant GMP experience in Medical Products industry
- 7 years of Management experience
- Previous FDA or other Ministry of Health audit experience
- Six Sigma Black Belt 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.
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.