Demo

Quality Assurance Manager

CSL Behring
Bradley, IL Full Time
POSTED ON 4/7/2025
AVAILABLE BEFORE 5/5/2025

Job Overview

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. As a Quality Assurance Manager, you will play a critical role in ensuring the quality of our products and processes.

About the Role

We are seeking an experienced professional to oversee quality-related activities within a Value Stream. The successful candidate will be responsible for ensuring adherence to applicable CSL standards and procedures, supporting and approving quality risk assessments, non-conformances, investigations, CAPAs, and change controls.

Main Responsibilities

  • Oversee quality-related activities within a Value Stream, including operational quality oversight for the area and for the processes.
  • Ensure adherence to applicable CSL standards and procedures via review and approval of related records.
  • Support and approve quality risk assessments, non-conformances, investigations, CAPAs, and change controls.
  • Monitor and continuous improvement of quality performance metrics.
  • Partner with all teams within the Value Stream regarding product quality aspects.
  • Responsible for support and oversight of manufacturing shop floor quality, shop floor hygiene/sterility assurance.
  • Agency audit participation, including assisting in the presentation of quality investigations and decisions to health authorities.
  • Maintains a current status for department GMP training requirements and provides oversight to onboarding training to department personnel.
  • Accountable to manage all batch documentation review per unit operations and issue batch disposition recommendation within deviation investigations.
  • Requirements

    To be successful in this role, you will need:

    • A University degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
    • 5 years' GMP experience in pharmaceutical/biotech/or other regulated industry
    • Experience within a global matrix organization
    • Knowledge of current Good Manufacturing Practices (cGMP) principles
    • Knowledge of appropriate regulatory requirements

    About CSL Behring

    CSL Behring is a global organization with employees in 35 countries. We are committed to the wellbeing of our employees and their loved ones, offering resources and benefits to support their needs.

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