Global Regulatory Compliance & Validation Lead

Medline Industries, LP; Mundelein (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 Industries, LP seeks a senior leader to drive pharmaceutical validation engineering, laboratory quality assurance, and risk management across the organization. You will oversee validation programs, GLP compliance, and global risk controls for pharmaceuticals, medical devices, and cosmetics.

The role requires expertise in cGMP, FDA/ISO standards, and global regulatory alignment, with travel up to 35%. A strong leadership background and relevant scientific/engineering degree are essential.

Qualifications

• Bachelor’s degree with a scientific or engineering background.
• At least 5 years of experience in a multi-discipline role in medical device and pharma Quality Management Systems including validations, risk management, laboratory systems.
• At least 2 years of experience managing people; including hiring, developing, motivating and directing people as they work.
• Experience with FDA regulations (21 CFR 820, 21 CFR 210/211).
• Experience with ISO 13485 & 17025.
• Experience with MDSAP and MDD/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 validation process program development and strategies to support manufacturing of pharmaceutical products.
• Audit and oversee validation of facility utilities, equipment processes and cleaning for cGMP products to adhere to regulatory requirements.
• Manage supplier master validation plans and audit suppliers for compliance.
• Develop global risk management program and drive improvements across products and processes.
• Oversee global Risk Management personnel for cGMP products and systems compliance.
• Collaborate with international risk management partners to align processes and meet global regulations.
• Provide training to personnel globally on validations, risk management, corrective actions, and quality systems compliance.

Skills

Regulatory compliance knowledge

Leadership

Analytical skills

Communication

Microsoft Word

Microsoft Excel

Education

Bachelor’s degree in engineering, chemistry or biological sciences

Tools

Microsoft Word

Microsoft Excel

Job description

Medline Industries, LP seeks a senior leader to drive pharmaceutical validation engineering, laboratory quality assurance, and risk management across the organization. You will oversee validation programs, GLP compliance, and global risk controls for pharmaceuticals, medical devices, and cosmetics.

The role requires expertise in cGMP, FDA/ISO standards, and global regulatory alignment, with travel up to 35%. A strong leadership background and relevant scientific/engineering degree are essential.