Site Quality Leader: Regulatory Excellence & Impact

Baxter International Inc.; Aibonito (PR); On-site; USD 168,000 - 231,000; Full time

Benefits offered by this job

Health and dental coverage

ESPP

401(k) Retirement Savings Plan

Paid time off 20–35 days

Job summary

Baxter International Inc. is seeking a Quality Site Head to lead the Quality Management System at the plant, partnering with site and business leadership to ensure regulatory compliance and drive continuous improvement.

The role supports regulatory inspections, quality performance, and delivering products that improve patient outcomes globally. The successful candidate will have extensive quality leadership experience in manufacturing, deep knowledge of FDA regulations and GMP, and a proven

Qualifications

• Bachelor’s degree in Engineering, Science, or related technical discipline required; advanced degree preferred.
• Minimum of 10 years of experience in Quality, Manufacturing or related functions.
• At least 7 years of progressive quality leadership experience, ideally within a global organization.
• Strong knowledge of FDA regulations, Quality Systems, GMP and regulatory compliance requirements.
• Experience 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.

Responsibilities

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

Skills

FDA regulations

GMP knowledge

Quality leadership

Regulatory compliance

Cross-functional collaboration

Education

Bachelor’s degree in Engineering/Science

Advanced degree preferred

Tools

Quality Management System (QMS)

Job description

Baxter International Inc. is seeking a Quality Site Head to lead the Quality Management System at the plant, partnering with site and business leadership to ensure regulatory compliance and drive continuous improvement.

The role supports regulatory inspections, quality performance, and delivering products that improve patient outcomes globally. The successful candidate will have extensive quality leadership experience in manufacturing, deep knowledge of FDA regulations and GMP, and a proven