Global Head of Regulatory Compliance & Validation

Medline; Northfield Township (IL); On-site; USD 140,000 - 210,000; Full time

Job summary

Medline seeks a senior leader to drive pharmaceutical validation engineering, laboratory QA, and risk management across global operations. You will oversee validation programs for compounding, filling and cleaning, applying chemistry, engineering and microbiology principles to meet regulatory requirements.

You will also manage the Laboratory Quality Assurance Unit to ensure GLP compliance and integrate risk management across products and processes in pharmaceuticals, medical devices, and

Qualifications

• Bachelor's degree in science or engineering with 5+ years in medical device/pharma QMS.
• Experience with FDA 21 CFR 820/210/211 and ISO 13485/17025.
• Proven leadership and cross-functional collaboration across validation, QA, and risk.

Responsibilities

• Lead and manage validation engineering, QA, and risk management teams for regulatory compliance.
• Oversee validation of facility utilities, equipment processes and cleaning for cGMP products.
• Audit suppliers and approve validation protocols and reports.
• Develop global risk management programs for pharmaceutical, medical devices, cosmetics.
• Ensure readiness for FDA/ISO inspections and corrective action programs.
• Provide global training on validation, risk management, and quality systems.
• Manage budgets, policies, and staff hiring and performance reviews.

Skills

Regulatory compliance

Quality management

Risk management

Validation engineering

Leadership

People management

FDA regulations

cGMP knowledge

ISO 13485/17025

Education

Bachelor's degree in science or engineering

Tools

GLP

Job description

Medline seeks a senior leader to drive pharmaceutical validation engineering, laboratory QA, and risk management across global operations. You will oversee validation programs for compounding, filling and cleaning, applying chemistry, engineering and microbiology principles to meet regulatory requirements.

You will also manage the Laboratory Quality Assurance Unit to ensure GLP compliance and integrate risk management across products and processes in pharmaceuticals, medical devices, and