Project Manager III

The Fountain Group is a national staffing firm and we are currently seeking a ­­­­­­­­Manager, Quality Systems for a prominent client of ours.  This position is in Lake County, IL 60064. Details for the position are as follows:

Location: Lake County, IL 60064 (100% Onsite)
Duration: 9-Month Contract
Pay Rate: $92–98/hour
Schedule: Monday – Friday, 40 hours/week

Position Summary

We are seeking an experienced Manager, Quality Systems to support Quality Assurance initiatives within a highly regulated pharmaceutical manufacturing environment. This individual will provide strategic and operational quality support focused on Supplier Quality Management, ensuring supplier performance, quality systems, and regulatory compliance meet corporate and global regulatory requirements.

The ideal candidate will possess extensive experience in pharmaceutical and/or medical device manufacturing, supplier quality systems, quality agreements, and quality metrics. This role partners closely with Manufacturing, Procurement, Supply Chain, Regulatory Affairs, Engineering, and external suppliers to drive continuous improvement, supplier performance, and compliance across the product lifecycle.

Key Responsibilities

• Lead Supplier Quality activities supporting pharmaceutical, biologics, medical device, cosmetic, and combination product manufacturing.
• Develop, prepare, and maintain supplier quality scorecards to evaluate supplier performance using quality metrics and key performance indicators (KPIs).
• Analyze supplier quality trends, identify recurring issues, and recommend corrective and preventive actions (CAPAs) to improve supplier performance.
• Create, review, negotiate, and maintain Quality Agreements with suppliers to ensure compliance with regulatory and corporate quality requirements.
• Support Supplier Controls and Supplier Qualification activities throughout the supplier lifecycle.
• Monitor supplier quality performance through data trending, quality intelligence, and risk assessments.
• Utilize SAP and electronic quality management systems (eQMS) to manage supplier quality documentation, quality records, and reporting.
• Ensure compliance with FDA, cGMP, ISO, and internal quality system requirements.
• Collaborate with cross-functional teams including Procurement, Supply Chain, Manufacturing, Engineering, Regulatory Affairs, and Operations to resolve supplier quality issues.
• Support quality system activities including document management, training, validation, labeling, quality intelligence, and quality compliance initiatives.
• Translate strategic quality objectives into tactical plans that support business goals and regulatory expectations.
• Participate in supplier investigations, deviation management, change control, root cause analysis, CAPAs, and continuous improvement initiatives.
• Support internal and external audits, supplier audits, and regulatory inspections.
• Prepare quality metrics, dashboards, reports, and executive-level presentations to communicate supplier performance and quality trends.
• Drive continuous improvement initiatives that strengthen supplier quality systems and overall operational excellence.

Required Qualifications

• Bachelor's degree in Life Sciences, Biology, Chemistry, Engineering, or a related scientific discipline.
• 8+ years of Quality Assurance experience within pharmaceutical and/or medical device manufacturing.
• Strong experience supporting Supplier Controls and Supplier Quality Management programs.
• Hands-on experience developing supplier scorecards and performing supplier quality tracking and trending.
• Experience creating, reviewing, and managing Quality Agreements.
• Experience using SAP in a quality or manufacturing environment.
• Excellent written and verbal communication skills with the ability to collaborate across cross-functional teams.
• Strong understanding of cGMP, FDA regulations, Quality Systems, and supplier compliance requirements.

Preferred Qualifications

• ASQ Certification (CQE, CQA, or equivalent).
• Experience with Veeva Vault.
• Experience with OneTrack/SolTRAQs.
• Experience working with Quality Intelligence, Validation, Training, Labeling, or Document Control functions.
• Experience supporting biologics, combination products, cosmetics, or medical device manufacturing.
• Strong analytical skills with experience using quality metrics, KPI reporting, and supplier performance dashboards.

Top Skills

• Supplier Quality Management & Supplier Controls
• Supplier Scorecards & Quality Metrics Trending
• Quality Agreements
• SAP
• Pharmaceutical or Medical Device Quality Systems
• cGMP & FDA Compliance
• Cross-Functional Collaboration
• Root Cause Analysis & CAPA
• Quality Data Analysis & Reporting
• Excellent Written & Verbal Communication