Site Quality Leader & Compliance Chief

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

Job summary

Baxter is seeking a Quality Site Head to lead the site Quality Management System and coordinate with site and business leadership to ensure regulatory compliance and drive continuous improvement. You will shape strategy, lead a high-performing quality organization, and influence product quality globally.

The role requires extensive experience in quality leadership, GMP, and FDA compliance, with a focus on delivering safe, effective products and improving patient outcomes worldwide.

Qualifications

• Bachelor’s degree in Engineering, Science, or related technical discipline (advanced degree preferred).
• Minimum 10 years of experience in Quality/Manufacturing within medical device/pharma/healthcare.
• At least 7 years of progressive quality leadership in a global organization.
• Strong knowledge of FDA regulations, GMP, and regulatory compliance.

Responsibilities

• Provide leadership for the site Quality Management System (QMS) and continuous improvement.
• Serve as site Quality Management Representative ensuring regulatory and Baxter requirements.
• Lead preparations for regulatory inspections and external audits.
• Establish measurable quality objectives aligned with priorities.
• Oversee planning, staffing, development, and budgeting of the site quality org.
• Evaluate and document product safety risks and manage communications.
• Maintain GMP compliance and oversee critical quality systems.
• Lead management reviews and report quality performance to senior leadership.

Skills

Leadership

FDA regulations knowledge

Cross-functional influence

Manufacturing process understanding

Education

Bachelor’s degree in Engineering/Science

Advanced degree preferred

Job description

Baxter is seeking a Quality Site Head to lead the site Quality Management System and coordinate with site and business leadership to ensure regulatory compliance and drive continuous improvement. You will shape strategy, lead a high-performing quality organization, and influence product quality globally.

The role requires extensive experience in quality leadership, GMP, and FDA compliance, with a focus on delivering safe, effective products and improving patient outcomes worldwide.