Quality Site Head

RXinsider LTD.; Aibonito (PR); Hybrid; USD 168,000 - 231,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Employee assistance program

Job summary

Baxter is seeking a Quality Site Head to lead the Quality Management System at the site, partnering with leadership to ensure regulatory compliance, drive improvements, and support inspections. You will shape strategy, oversee a high-performing quality organization, and deliver products that improve patient outcomes worldwide.

The role requires a strong background in FDA regulations, GMP, and global quality leadership, with at least 10 years in related functions and 7 years in leadership.

Qualifications

• Bachelor’s degree in Engineering, Science, or a related technical discipline is required; advanced degree preferred.
• Minimum of 10 years in Quality, Manufacturing or related functions in medical devices, pharma, or healthcare.
• At least 7 years of progressive quality leadership experience, ideally global.
• Strong knowledge of FDA regulations, GMP, and regulatory compliance requirements.
• Experience leading quality organizations in complex manufacturing environments.

Responsibilities

• Provide leadership and governance for the site Quality Management System (QMS).
• Serve as the site Quality Management Representative and ensure regulatory compliance.
• Lead preparations for and management of regulatory inspections and external audits.
• Establish and monitor measurable quality objectives aligned with priorities.
• Direct planning, staffing, development, and budgeting of the site quality organization.
• Ensure evaluation and management of product safety risks and documentation.
• Maintain GMP compliance and oversee critical quality systems and processes.
• Review and approve quality-related procedures, specifications, and records.
• Lead management review activities and report quality system performance to senior leadership.

Skills

Quality leadership

FDA regulations

GMP knowledge

Cross-functional influence

Manufacturing knowledge

Education

Bachelor’s degree in Engineering/Science

Advanced degree preferred

Tools

Quality Management System (QMS)

Job description

This is whereyour 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 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.

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.

Know Your Rights: Workplace Discrimination is Illegal

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.