Quality Assurance Manager

Role: Quality Assurance Manager

Location: Waukegan, IL

About the Role

We are seeking an experienced Quality Systems Manager to support and enhance our global Quality Systems and Supplier Risk Management programs. This individual will work across multiple manufacturing sites—supporting pharmaceuticals, medical devices, biologics, cosmetics, and combination products—to ensure compliance with corporate standards and global regulatory requirements.

Key Responsibilities

• Lead and support Quality Systems and Supplier Risk Management activities at a global scale.
• Develop, revise, and maintain Quality System procedures, controlled documents, and process standards.
• Manage and coordinate Supplier Controls, including supplier quality activities, performance monitoring, and issue resolution.
• Collaborate with global teams (US, Europe, Asia) and multiple manufacturing sites to align quality processes and ensure compliance.
• Organize cross-functional meetings, track follow-ups, and drive completion of quality-related action items.
• Translate strategic quality initiatives into actionable plans and ensure timely execution.
• Support additional QA areas such as Document Control, Device QA, Validation, Labeling, Training, and Quality Intelligence.
• Ensure compliance with Corporate Quality Standards, FDA, ISO, and other international regulations.

Qualifications

• Bachelor’s degree in Life Sciences or related field (strongly preferred).
• 8 years of Quality experience in pharmaceutical, medical device, biologics, or GMP-regulated environments.
• Strong expertise in writing Quality System procedures, SOPs, and controlled documents.
• Extensive experience in Supplier Controls and supplier quality management.
• Excellent communication skills with the ability to collaborate across global teams.
• Experience with TrackWise or similar eQMS platforms is highly preferred.
• ASQ certification is a plus.