Job Title: Quality Assurance Manager
Location: Waukegan, IL
Experience: 8+ years
Contract Duration: 12+ months with potential extension
Work Authorization: Candidates open to relocation are welcome. Relocation assistance is not provided.
The Quality Assurance Manager is responsible for leading and supporting quality system activities across regulated manufacturing environments. This role ensures compliance with applicable regulatory requirements and internal quality standards across the full product lifecycle, from raw material receipt through final product release and distribution. The position supports both strategic initiatives and hands-on execution of quality system processes within pharmaceutical and or medical device manufacturing.
Key ResponsibilitiesProvide quality assurance leadership and oversight for regulated manufacturing processes, including pharmaceuticals, medical devices, cosmetics, combination products, and biologics as applicable
Ensure quality systems align with corporate policies and global regulatory requirements
Translate quality strategy into actionable, tactical objectives to support business and compliance goals
Lead and support quality system functions such as Document Control, Device Quality Assurance, Labeling, Validation, Training, Supplier Quality, and Quality Intelligence
Oversee the development, review, and maintenance of Quality System procedures, work instructions, and process documentation
Ensure product, process, and system quality activities comply with FDA, ISO, and other applicable global regulations
Manage supplier controls including qualification, monitoring, audits, and performance management
Support regulatory inspections, internal audits, and quality system assessments
Review and assess quality impact of process changes, deviations, investigations, and CAPAs
Collaborate cross-functionally with Manufacturing, Engineering, Regulatory Affairs, and Supply Chain teams
Provide guidance and mentorship to quality team members and stakeholders
Monitor quality metrics and drive continuous improvement initiatives
Bachelor's degree in Life Sciences or a related scientific discipline
Minimum of 8 years of experience in Quality within pharmaceutical or medical device manufacturing
Strong working knowledge of quality systems and regulatory compliance requirements
Proven experience writing and maintaining Quality System procedures and process documents
Hands-on experience with supplier quality and supplier control processes
Excellent written and verbal communication skills
Ability to translate regulatory and quality requirements into practical business solutions
Experience supporting inspections, audits, and regulatory interactions
Experience supporting multiple regulated product types
Exposure to validation, labeling, and training systems
Leadership experience within quality organizations
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