Project Manager III

The Fountain Group is a national staffing firm and we are currently seeking a
Quality Systems Manager
for a prominent clientofours. This position is in
North Chicago, IL 60064.Details for the position are as follows:

Relocation:Candidates may relocate
at their own expense

On-Site in North Chicago, IL (M–F, 40 hrs./week)

The Manager, Quality Systems is responsible for providing comprehensive Quality Assurance support across manufacturing operations for pharmaceutical products, medical devices, cosmetics, biologics, and combination products. This role ensures that quality processes, documentation, and systems are aligned with corporate quality standards and fully compliant with applicable regulatory requirements.

The Manager will support strategic Quality initiatives, translate organizational goals into actionable plans, and help drive continuous improvement across the Quality System. Areas of responsibility may include Document Control, Device QA, Labeling, Validation, Training, and Quality Intelligence.

• Lead and support Quality System activities to ensure compliance with corporate procedures, FDA regulations, ISO standards, and other applicable requirements.
• Develop, revise, and maintain
  Quality System procedures, SOPs, work instructions, and process documents
  .
• Support and oversee
  Supplier Controls
  , including qualification, monitoring, risk assessments, and remediation activities.
• Ensure that all product, process, and system-related quality activities—from raw material inspection through release and shipment—meet required standards.
• Partner with cross-functional teams (Manufacturing, QA, Regulatory, Labeling, Validation, Document Control, Training) to ensure alignment and execution of quality objectives.
• Evaluate quality data and trends to drive process improvements and support Quality Intelligence initiatives.
• Assist with audits, inspections, and readiness activities as needed.
• Translate strategic quality goals into tactical deliverables that support business and regulatory expectations.
• Maintain inspection readiness across quality documentation and systems.

• Bachelor’s degree in Life Sciences
  (Biology, Chemistry, Engineering, etc.)
• 8+ years of Quality experience
  within pharmaceutical, medical device, biologics, cosmetic, or combination product manufacturing
• Demonstrated experience writing and maintaining
  Quality System procedures and process documents
• Strong background in
  Supplier Controls
  and supplier quality oversight
• Excellent
  written and verbal communication skills
• Solid understanding of regulated manufacturing environments and compliance requirements (FDA, cGMP, ISO 13485, etc.)

• ASQ certification
  (e.g., CQA, CQE, CMQ/OE)
• Experience supporting cross-functional quality areas such as Labeling, Validation, Training, Document Center, or Device QA
• Familiarity with quality metrics, trend analysis, or Quality Intelligence tools
• Experience leading quality-related projects or system improvements