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Sr. Manager, Quality Systems

Skokie, IL 60077

Posted: 03/17/2025 Employment Type: Direct Hire Job Category: Quality Job Number: 4318

Job Description

As the Senior Manager, Quality Systems, you will play a crucial role in ensuring that operations, documentation, and data are late-stage inspection ready. You will serve as the system owner for electronic QMS and data platforms, and as the process owner for Quality Management Review and Supplier Quality Management (including Audit) programs. Your contributions will support both preclinical research and early-stage manufacturing processes. This role will report to Vice President, Quality; and be part of the leadership team within Quality.

What You'll Do
  • Oversee the use and continuous improvement of processes and electronic systems associated with Document Management, Training, Change Control, and Deviation/CAPA.
  • Own and oversee use and continuous improvement of Data Governance, Supplier Quality, Risk Management, Audit/Self-inspection, and Validation processes and electronic systems.
  • Own and lead Quality Management Review process and related KPI trending and reporting forums.
  • Build and lead a small team of both FTE and contract specialists.
  • Lead and/or participate in supplier and internal audits.
  • Represent Quality and provide insight and action in defined cross-functional teams.
  • May have responsibility for aspects of EH&S program, depending on experience
     
Qualifications
  • B.S or M.S. in Engineering, Science, or Regulatory Compliance
  • 8+ years of Pharma/Biotech industry experience with 5+ in Quality roles
  • Track record of ownership of eQMS systems and/or workflows
  • Strong background in systems-based validation
  • Experience in all aspects of Supplier Quality Management, including strategic planning, vendor evaluation/qualification, ongoing interaction and oversight, quality agreement ownership and application, and risk management.
  • Biotechnology/pharma industry experience in investigation/root cause analysis as well as trend analysis for continuous improvement.
  • ASQ or similar Auditor certification a plus
  • Background in EH&S compliance a plus but not required
     
The level of this position will be based on the final candidate’s qualifications.

 
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About Skokie, IL

Ready to kickstart your career in Skokie, Illinois? This vibrant suburb of Chicago offers a perfect blend of urban amenities and suburban charm, making it an ideal place to grow both personally and professionally. From the delightful Skokie Farmers' Market to the world-renowned Skokie Sculpture Park, this area is brimming with cultural attractions and recreational opportunities. Discover the charm of Skokie's diverse dining scene, catch a performance at the Skokie Theatre, or explore the stunning collections at the Illinois Holocaust Museum & Education Center. With easy access to downtown Chicago and top-notch schools in the area, Skokie provides a perfect balance for both work and play. Explore our job listings in Skokie today and take the next step towards an exciting career in this bustling community.