Global Regulatory Compliance & Validation Leader

Medline Industries, Inc.; Northfield (MN); On-site; USD 120,000 - 170,000; Full time

Job summary

Medline Industries, Inc. is seeking a senior leader to oversee pharmaceutical validation engineering, laboratory quality assurance, and risk management across global operations.

This role ensures regulatory compliance for cGMP products, medical devices, cosmetics, and OTC drugs through engineering, chemistry, and microbiology principles. You will provide management oversight of validation programs, QA systems, and risk controls, aligning with FDA, ISO, GLP, and MDSAP requirements while driving

Qualifications

• Bachelor's degree in a scientific or engineering field.
• 5+ years in a multi-discipline role in medical device and pharma Quality Management Systems including validations, risk management, laboratory systems.
• 2+ years of experience managing people; including hiring, developing, motivating and directing people.
• Experience with FDA regulations (21 CFR 820, 21 CFR 210/211).
• Experience with ISO 13485 & 17025.
• Experience with MDSAP and MDR regulations.
• Experience applying knowledge of process validation, method validation and GLP requirements.
• Experience with FDA inspections and FDA 483 response writing.
• Experience with Risk Management global expectations.

Responsibilities

• Lead the development and oversight of validation processes, master validation plans, and strategies across pharmaceutical manufacturing.
• Oversee validation of facility utilities, equipment processes and cleaning for cGMP products to meet regulatory requirements.
• Manage global risk management programs and strategies supporting products and processes.
• Coordinate with international Risk Management partners to ensure consistent risk analysis and controls.
• Oversee Laboratories Quality Assurance ensuring GLP compliance and quality systems integration.
• Provide training to personnel globally on validations, risk management, corrective actions, and quality systems compliance.

Skills

FDA regs

QA leadership

Risk mgmt

GLP knowledge

Quality systems

MDSAP/MDR

FDA inspections

Process validation

Education

Bachelor's degree in science/engineering

Job description

Medline Industries, Inc. is seeking a senior leader to oversee pharmaceutical validation engineering, laboratory quality assurance, and risk management across global operations.

This role ensures regulatory compliance for cGMP products, medical devices, cosmetics, and OTC drugs through engineering, chemistry, and microbiology principles. You will provide management oversight of validation programs, QA systems, and risk controls, aligning with FDA, ISO, GLP, and MDSAP requirements while driving