Associate Director, Quality - Business Development & External Contract Manufacturing

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. 

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.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. 

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission. 

Your Role at Baxter
 

This is where your creativity addresses challenges
 

You are creative, thorough, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next. As the Associate Director, Quality, you are unafraid of navigating through necessary internal processes to facilitate a product you deeply believe in. You can absorb and act on complex procedures and data and train your team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality.
 

Your Team at Baxter
 

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.
 

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.
 

The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products.
 

We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.
 

The Associate Director, Quality is responsible for leading quality oversight, strategy, and compliance across global external manufacturing partners (ECMs). In this role you will ensure that ECMs meet company and regulatory standards while supporting business development initiatives to expand and optimize external partnerships. The position requires strong leadership, operational excellence, and critical thinking to maintain compliance throughout a global network. You will assure systems and procedures for regulatory compliance are established and deployed while periodically reviewing the suitability and effectiveness of the quality system with executive management.
 

What you'll be doing

• Lead a global team responsible for quality oversight of external manufacturing partners (ECMs). Develop and mentor direct reports, encouraging a high-performance and compliance-driven culture
• Establish and maintain a robust quality governance framework for external contract manufacturers.
• Ensure all ECM partners follow global regulatory requirements (e.g., FDA, EMA, MHRA, ICH, GMP).
• Lead risk assessments and implement mitigation strategies for external manufacturing operations.
• Monitor audits, inspections, and qualification of ECM's ensuring timely resolution of quality issues.
• Collaborate with business development, supply chain, and technical operations teams to assess and onboard new external partners. Provide quality input during due diligence and contract negotiations with ECMs.
• Provide quality input during due diligence and contract negotiations with ECMs.
• Lead New Product Development and Tech Transfer as quality rep, as needed.
• Periodically reviews the suitability and effectiveness of the quality system with executive management.
• Assesses and advises senior management concerning acquisition targets.
• Interacts frequently with all levels of internal management as well as across f