Global Process & Compliance Center Lead

Medline; Northfield Township (IL); Hybrid; USD 154,000 - 231,000; Full time

Benefits offered by this job

Health insurance

Job summary

Medline is seeking a Senior Manager Regulatory Compliance to lead pharmaceutical validation engineering, laboratory QA, and risk management across global operations. The role oversees validation programs for manufacturing and cleaning, and ensures compliance with 21 CFR 211/210, 21 CFR 820, ISO 13485, 17025, and MDSAP requirements.

The incumbent will manage global risk controls for pharma, medical devices, and cosmetics, align risk processes, and support FDA/ISO inspections with robust

Qualifications

• Bachelor’s degree in a scientific or engineering field.
• At least 5 years in a multi-discipline role in medical device and pharma QMS including validations, risk management, and laboratory systems.
• Experience with FDA regulations (21 CFR 820, 210/211) and ISO 13485 & 17025.
• Experience with MDSAP and MDD/MDR regulations.
• Experience with FDA inspections and FDA 483 responses.

Responsibilities

• Lead the development and management of the validation process program and master validation plan.
• Oversee validation of facility utilities, equipment, and cleaning for cGMP products.
• Audit suppliers and approve validation protocols and reports.
• Develop and manage global risk management programs and continuous improvement.
• Support FDA and ISO inspections and implement corrective actions.

Skills

Regulatory compliance

Quality management systems

Validation engineering

Risk management

FDA regulations

Education

Bachelor's degree in science/engineering

Tools

Microsoft Word

Microsoft Excel

Job description

Medline is seeking a Senior Manager Regulatory Compliance to lead pharmaceutical validation engineering, laboratory QA, and risk management across global operations. The role oversees validation programs for manufacturing and cleaning, and ensures compliance with 21 CFR 211/210, 21 CFR 820, ISO 13485, 17025, and MDSAP requirements.

The incumbent will manage global risk controls for pharma, medical devices, and cosmetics, align risk processes, and support FDA/ISO inspections with robust