Global Regulatory Compliance & Validation Director

Medline; Chicago (IL); On-site; USD 154,000 - 231,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline is seeking an experienced senior leader to manage pharmaceutical validation engineering, laboratory quality assurance, and risk management across the organization. The role oversees validation for compounding, filling, and cleaning of drug products and related equipment, applying engineering, chemistry, and microbiology principles to meet regulatory requirements.

The position also leads the Global Risk Management program and the Laboratory Quality Assurance Unit, ensuring GLP compliance

Qualifications

• Bachelor’s degree in science or engineering.
• 5+ years in a multi-discipline medical device and pharma QMS.
• 2+ years of people management experience.
• Experience with FDA regulations (21 CFR 820, 210/211).
• Experience with ISO 13485 & 17025.
• Experience with MDSAP and MDD/MDR regulations.
• Experience with process validation, method validation and GLP.
• Experience with FDA inspections and FDA 483 responses.
• Willing to travel up to 35% for business purposes.

Responsibilities

• Lead validation process program and master validation plan.
• Identify and drive opportunities to improve validation systems.
• Oversee facility utilities validation and cleaning for cGMP products.
• Audit suppliers for validation compliance.
• Review validation protocols and reports.
• Develop global risk management program and strategies.
• Lead risk management teams for global product/process controls.
• Coordinate with international risk management partners.
• Provide global training on validations, risk management, and quality systems.

Skills

Regulatory compliance

Quality management

Risk management

Leadership

Education

Bachelor's degree in engineering or science

Tools

Microsoft Word

Microsoft Excel

Job description

Medline is seeking an experienced senior leader to manage pharmaceutical validation engineering, laboratory quality assurance, and risk management across the organization. The role oversees validation for compounding, filling, and cleaning of drug products and related equipment, applying engineering, chemistry, and microbiology principles to meet regulatory requirements.

The position also leads the Global Risk Management program and the Laboratory Quality Assurance Unit, ensuring GLP compliance