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.

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.

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.

• 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 functions and business units.
• Manages interactions with customers and regulators concerning the quality of products, systems and processes.
• Identifies and leads continuous improvement projects that may span multiple sections or departments with the objective of achieving quality, reliability and cost improvements.
• Responsible for adherence to specifications and procedures that have been established to ensure product quality in area of responsibility.
• Develops budget for a mid to large size plant of large program / department and ensures adherence to the budget.
  

• BS in science or engineering; advance degree helpful.
• Minimum 10 years of experience in pharmaceutical quality preferred, with a strong focus on external manufacturing and business development.
• In depth knowledge of the regulatory environment for manufacture of pharmaceutical products. Strong knowledge of GMP, ICH guidelines, and international regulatory requirements
• Strong leadership skills and proven success in managing a large team.
• Strong analytical and problem-solving skills.
• Excellent verbal and written communication skills.
• Success working with multifunctional, global teams.
• Excellent interpersonal, communication, influencing, negotiation skills are required.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $152,000 - $209,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. 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. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses and long-term incentive. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

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US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees.For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

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.

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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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