Quality Site Head

Zvh; Aibonito (PR); On-site; USD 168,000 - 231,000; Full time

Benefits offered by this job

Health coverage

Stock plan

401(k) matching

Paid time off

Parental leave

Education assistance

Job summary

Baxter is seeking a Quality Site Head to lead the plant's Quality Management System and act as the Quality Management Representative, ensuring regulatory compliance and driving a culture of continuous improvement. You will partner with site and business leadership to deliver products that improve patient outcomes worldwide.

You will shape site quality strategy, lead a high-performing team, and oversee external audits, with a focus on GMP, regulatory compliance, and cross-functional

Qualifications

• Bachelor’s degree in Engineering, Science, or a related technical discipline.
• Minimum 10 years in Quality/Manufacturing or related within medical devices, pharmaceuticals, or healthcare products.
• At least 7 years progressive quality leadership experience, ideally within a global organization.
• Strong knowledge of FDA regulations, Quality Systems, GMP and regulatory compliance requirements.
• Demonstrated success leading quality organizations in complex manufacturing environments.
• Experience managing multiple priorities, driving results through ambiguity, and influencing cross-functional stakeholders.

Responsibilities

• Provide overall leadership and governance for the site Quality Management System (QMS).
• Serve as the site Quality Management Representative and ensure regulatory, customer, and Baxter quality requirements compliance.
• Lead preparations for and management of regulatory inspections and external audits.
• Establish, communicate, and monitor measurable quality objectives aligned with business priorities.
• Direct the planning, staffing, development, and budgeting of the site quality organization.
• Ensure effective evaluation, management communication, and documentation of product safety risks.
• Maintain GMP compliance across the site and oversee critical quality systems and processes.
• Review and approve quality-related procedures, specifications, records, and product disposition decisions.
• Lead management review activities and provide regular updates to senior leadership regarding quality system performance and improvement opportunities.

Skills

Quality leadership

Regulatory knowledge

FDA regulations

GMP knowledge

Cross-functional collaboration

Strategic planning

Education

Bachelor’s degree in Engineering/Science

Job description

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves 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 job—you will find purpose and pride.

Your Role As the Quality Site Head, you will serve as the Quality Management Representative for the plant and provide leadership across all quality functions. You will partner closely with site and business leadership to ensure compliance with applicable regulations and standards, support regulatory inspections, drive quality performance, and strengthen a culture of continuous improvement. This role offers the opportunity to influence site strategy, lead a high-performing quality organization, and play a critical role in delivering products that improve patient outcomes around the world.

Your Team Every role within Quality makes a difference. Baxter's products reach patients worldwide. Individuals in Quality either develop new processes or solve new production challenges. They are trusted and encouraged to apply creativity. Your specific role will influence a part 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.

What you'll be doing Provide overall leadership and governance for the site Quality Management System (QMS), ensuring requirements are effectively established, maintained, and continuously improved. Serve as the site Quality Management Representative and ensure compliance with applicable regulatory, customer, and Baxter quality requirements. Lead preparations for and management of regulatory inspections and external audits. Establish, communicate, and monitor measurable quality objectives aligned with business and quality priorities. Direct the planning, staffing, development, and budgeting of the site quality organization. Ensure effective evaluation, management, communication, and documentation of product safety risks. Maintain GMP compliance across the site and oversee critical quality systems and processes. Review and approve quality-related procedures, specifications, records, and product disposition decisions. Lead management review activities and provide regular updates to senior leadership regarding quality system performance and improvement opportunities.

What you'll bring Bachelor’s degree in Engineering, Science, or a related technical discipline required, advanced degree is preferred. Minimum of 10 years of experience in Quality, Manufacturing or related functions within the medical device, pharmaceutical or healthcare products industry. At least 7 years of progressive quality leadership experience, ideally within a global organization. Strong knowledge of FDA regulations, Quality Systems, Good manufacturing practices (GMP) and regulatory compliance requirements. Demonstrated success leading quality organizations in complex manufacturing environments. Experience managing multiple priorities, driving results through ambiguity, and influencing cross-functional stakeholders. Strong understanding of manufacturing processes, product configuration, and quality system methodologies.

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 $168,000-$231,000 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.

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.

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.

Know Your Rights: Workplace Discrimination is Illegal Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally.

Recruitment Fraud Notice

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.

No matter your role at Baxter, your talent, skills, and time has a direct impact on people's lives. Since 1931, we have been at the forefront of innovation by bringing smarter, more personalized care to patients around the world. Now, we're more determined than ever to make a lasting impact as we are redefining healthcare delivery across the care journey. Our Mission to Save and Sustain Lives motivates us as we create a culture in which each of us can succeed. This is where you belong.