Global Quality Site Leader: Impactful Patient Outcomes

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

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