Quality Site Leader: Regulatory & Quality Excellence

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

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.