Director, Quality Compliance - MPT

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 a Director, Quality Compliance, 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.

What you'll be doing

• Conducts segment management reviews with executive management

• Develop, implement, and maintain quality systems policies, procedures, and processes to ensure compliance with regulatory requirements, including FDA, EMA, and other relevant authorities.

• Provide strategic leadership and oversight for the management of quality systems, including but not limited to document control, change control, deviation management, CAPA, training, and audits.

• Understands and deploys processes to assure conformance to regulations in a mid to large size plant of a large program or department. Leads regulatory inspections.

• Collaborate with regulatory affairs teams to facilitate product registrations and submissions in compliance with regional and international regulations

• Conduct regular risk assessments to identify potential compliance vulnerabilities and develop strategies to mitigate risks effectively. Monitor changes in laws, regulations, and industry trends to anticipate and address emerging compliance issues proactively.

• Lead and participate in internal and external audits (ie clinical/preclinical, PV, and etc), inspections, and regulatory submissions, ensuring timely responses and resolution of any findings or observations.

• Identified 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.

• Collaborate cross-functionally with various departments, including Quality Assurance, Regulatory Affairs, Manufacturing, and R&D, to drive continuous improvement initiatives and ensure alignment with quality objectives.

• Supervise key performance indicators (KPIs), data analytics and metrics to assess the effectiveness of quality systems and identify areas for improvement.

• Stay abreast of regulatory developments, industry trends, and standard processes related to quality systems, and proactively implement vital changes to maintain compliance and enhance operational efficiency. Stay abreast of evolving global requirements, ensuring the organization's readiness for audits and inspections by regulatory authorities

• Incorporate knowledge of quality and regulatory requirements and research analysis to make recommendations to meet business unit plans.

• Provide leadership to team members, guiding them in terms of prioritization, problem resolution, process clarification, referrals to appropriate authorities, etc.

What you'll bring

• Bachelor's degree in a relevant scientific field; advanced degree preferred

• 10+ years' experience and direct management of global strategic quality in a complex, matrixed environment

• Fully developed special and scientific skills, long-term management experience

• Ability to recognize problems, problem definition, problem analysis and problem evaluation in familiar situations and independent decision making and decision implementation

• 7+ years' experience leading people

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 $176,000-242,000 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, commission, and/or 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.

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite at any Baxter location. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

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 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.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

137525