Overview
This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.
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Support for Parents
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Continuing Education/
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Paid Time Off
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2 Days a Year to Volunteer
Success Profile
What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.
- Detail Oriented
- Continuous Learner
- Courageous
- Collaborative
- Critical Thinker
- Influential
Director, Global Labeling
Vantive: A New Company Built On Our Legacy
Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.
At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.
*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.
The Director, Global Labeling Operations, Kidney Care will provide leadership, innovation and technical expertise for the creation, maintenance and implementation for customer-facing technical documentation and product labeling for all products to meet company objectives and country-specific regulatory requirements.
This role will report to the Head of Engineering and OpEx – Integrated Supply Chain and will manage a team of up to 25 – 50 people. The team is based in Malta in addition to staff in the U.S. This role will manage collaborative relationships with Research & Development, Marketing, Quality Assurance, Regulatory Affairs, Integrated Supply Chain (ISC) and other business functions.
Role and Responsibilities:
Set the strategic vision for Global Labeling organization to encourage global harmonization across functional areas and all countries
Owner of the Global Labeling process within the Global Quality Procedures (GQPs), accountable for the development, implementation, and continuous improvement of an effective process across the product portfolios, for all internal and external manufacturers
Responsible for all Baxter product labeling in all countries globally, including the New Product Introduction, Geographic Expansion and Sustaining portfolios for its business segments
Maintain awareness of global regulatory environments and assess impact of changes on Product Labeling activities
Leads key initiatives for process improvements, development of new tools, technologies to support efficient label development in support of submissions and product compliance
Required Qualifications:
The Director, Global Labeling Operations will have a successful track-record of experience and understanding in the following areas:
Bachelor’s Degree or equivalent education
12+ years of relevant work experience
Experience leading departmental Capital and Operating Expense budgets
Experience with implementing creative labeling strategies for both pharmaceuticals and medical device development programs
Understanding of FDA and EMA regulations and ICH guidelines, as well as comprehensive experience in the drug and medical device development process
Proven ability to think strategically, implement new processes, and make tough decisions
Strong executive presence with our global leaders and teams across multiple functions
Superb leadership, coaching, and people development skills
Ability to inspire and lead global teams
Preferred Qualifications:
Master’s Degree
Experience within the Pharmaceutical and/or Medical Device industries
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
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