Senior Manager, Supplier Quality & Audits

This is whereyour work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today tomorrow and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together our community is driven by a culture of courage trust and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations and we hold each other accountable for delivering exceptional results.

Here you will find more than just a jobyou will find purpose and pride.

As theSenior Director Divisional Quality Audit & Supplier Quality Programs you will lead strategic quality initiatives that strengthen compliance drive risk-based auditing and enhance supplier quality oversight across a global network of sites and suppliers.This is whereyoull influence enterprise-wide quality strategy improve inspection readiness and proactively identify and mitigate risks that impact product quality and patient safety. Success in this role will be measured by the effectiveness of audit and supplier quality programs regulatory compliance risk reduction and the development of high-performing teams that support operational excellence.

As part of Baxters Quality organization youll work with a highly collaborative team focused on advancing patient safety regulatory compliance and operational excellence. This team partners across the enterprise to identify risks drive quality improvements and ensure consistent execution of Baxters standards worldwide. Baxter supports your success through a culture of development meaningful work community involvement opportunities and comprehensive benefits.

• Lead the divisional internal audit program including audit strategy prioritization planning execution oversight reporting and governance across manufacturing compounding and design sites.
• Monitor audit results compliance trends quality risks and inspection outcomes to identify systemic issues and inform risk-based quality decisions.
• Oversee a global auditor network including auditor qualification development and program effectiveness.
• Partner with site and functional leaders to support inspection readiness remediation activities and ongoing compliance improvement efforts.
• Provide leadership and oversight for supplier quality programs including supplier risk management performance monitoring quality issues and remediation activities.
• Collaborate with Quality Regulatory Affairs Procurement Manufacturing and Operations teams to strengthen quality systems and supplier oversight across the organization.
• Lead and develop teams while balancing quality compliance and operational priorities across multiple programs and functions.
• Communicate quality program performance risks and key priorities to senior and executive leadership.

• Bachelors degree in Life Sciences Engineering or a related technical field.
• 10 years of experience in Quality Regulatory Affairs Manufacturing or a related regulated industry including 7 years of leadership experience and 5 years of auditing experience.
• Prior experience within the medical device industry is required; experience within pharmaceutical and/or biologics manufacturing environments is preferred.
• Strong knowledge of global regulatory requirements governing medical device manufacturing with familiarity in pharmaceutical and biologics regulations preferred.
• Demonstrated success leading large-scale quality compliance regulatory or manufacturing organizations including management of complex compliance issues risk assessments and quality improvement initiatives.
• Experience leading regulatory inspections and audit programs across global manufacturing operations including FDA inspection experience and oversight of multi-site audit programs.
• Expertise in regulated manufacturing environments with experience supporting product quality compliance and inspection readiness.
• Exceptional leadership communication and relationship-building skills with the ability to lead global cross-functional teams navigate complex challenges and drive results.
• Ability to travel up to 50% including domestic and international travel.

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 $136000 - $187000 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. 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.

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 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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