Project Manager, Quality Systems

Project Manager- Quality Systems
 North Chicago, IL (Onsite Only – M–F, 40 hrs/week)
$84–$89/hr (Rate depends on selected health benefit package)
6-Month Contract | Possible Extension


About the Role
We’re seeking an experienced Manager, Quality Systems to support Quality activities across pharmaceutical, medical device, biologics, cosmetics, and combination product operations. In this role, you will help translate strategic quality objectives into actionable plans while ensuring full compliance with Corporate, FDA, and global regulatory requirements.
You will collaborate with cross-functional teams across Quality, Manufacturing, and Regulatory to strengthen processes, drive continuous improvement, and support key Quality System elements including Document Control, Labeling, Validation, Training, Supplier Controls, and Quality Intelligence.

This is an excellent opportunity for a seasoned Quality professional who thrives in a fast-paced, regulated environment and is confident in writing procedures, interpreting regulations, and ensuring operational excellence.

Key Responsibilities

• Provide Quality Systems oversight across multiple product categories (pharma, devices, biologics, combination products, cosmetics).
• Write, revise, and maintain Quality System procedures, work instructions, and process documentation.
• Support Supplier Controls activities, ensuring vendors and partners align with applicable quality and compliance standards.
• Ensure all product, process, and system-related quality activities—from raw material inspection through finished goods release—meet internal and regulatory requirements.
• Translate Quality strategy into clear, tactical objectives for day-to-day operations.
• Support Quality functions such as Document Control, Device QA, Labeling, Validation, Training, and Quality Intelligence.
• Collaborate with internal stakeholders to interpret regulatory expectations and implement updates.
• Drive continuous improvement initiatives to enhance compliance, efficiency, and documentation quality.

Required Qualifications

• Bachelor’s degree in Life Sciences (or related field).
• 8 years of experience in Quality within pharmaceutical or medical device manufacturing.
• Strong proficiency writing and reviewing Quality System procedures and process documents.
• Experience with Supplier Controls in a regulated environment.
• Excellent written and verbal communication skills, with the ability to explain complex concepts clearly.

Nice to Have

• ASQ Certification (CQE, CQA, or similar).
• Experience supporting multiple Quality System elements (Validation, Document Control, Training, etc.).

Work Schedule

• Monday–Friday, 40 hours/week
• 100% Onsite
• Overtime may occur based on business needs but is not expected.

Who Thrives in This Role
This position is ideal for someone who:

• Is highly organized, detail-focused, and fluent in Quality System requirements.
• Enjoys writing, editing, and improving process documentation.
• Is comfortable advising cross-functional teams and supporting audits or regulatory updates.
• Understands the fast-paced nature of pharma/device manufacturing and can adapt to evolving expectations.

 

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.