Quality Systems Manager
Chem-Impex International, Inc.•Wood Dale, IL
•Onsite
About The Position
This is a hands-on Quality Systems leadership role responsible for owning and evolving our ISO 9001 Quality Management System (QMS). This role is critical to how we scale ensuring quality systems remain strong, consistent, and able to support increasing operational and customer demands without relying on reactive problem-solving.
Requirements
- 5–10+ years in Quality Systems / QA (chemical, pharma, or regulated manufacturing)
- Experience leading or developing a small team
- Strong working knowledge of ISO 9001 (cGMP familiarity preferred)
- Experience building or improving CAPA, change control, audits, or supplier quality systems
- Comfortable leading cross-functional governance forums (MRB, CRB, or similar)
- Degree in Chemistry, Chemical Engineering, or related field (or equivalent experience)
Nice To Haves
- ASQ certification (CMQ/OE, CQA) a plus
Responsibilities
- Own and continuously improve the ISO 9001 Quality Management System
- Maintain audit readiness across internal, customer, and third-party audits
- Manage document control (SOPs, Work Instructions) and training alignment
- Track and report weekly quality metrics and trends
- Ensure systems remain aligned with how work is carried out
- Lead the Material Review Board (MRB) for nonconforming materials
- Own nonconformance investigations from initiation through closure (internal and customer)
- Strengthen and standardize the CAPA system
- Drive structured root cause analysis (5 Whys, Fishbone, etc.)
- Manage quarantine inventory and material disposition
- Close Supplier Corrective Action Requests (SCARs)
- Lead Change Review Board (CRB) and change control governance
- Implement and maintain a risk-based change control framework
- Ensure consistent application across teams and functions
- Develop supplier qualification and performance programs
- Implement risk-based supplier segmentation and monitoring
- Partner cross-functionally to resolve supplier quality issues
- Improve SDS (Safety Data Sheet) lifecycle management and governance
- Ensure alignment across SDS, CoA, specifications, and internal records
- Establish standards for data integrity, traceability, and GHS compliance
- Manage equipment calibration program (no overdue items)
- Oversee chemical disposal program and vendor coordination
Benefits
- Medical, Dental, and Disability Insurance
- 401(k) with company match
- Paid Time Off
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What This Job Offers
Job Type
Full-time
Career Level
Senior
