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Senior Quality Compliance Manager

Company: CSL Behring
Location: Kankakee
Posted on: August 3, 2022

Job Description:

CSL Behring in Kankakee, Illinois has grown into a global biotechnology leader, driven by that same promise to save and improve lives. We offer the broadest range of quality plasma-derived and recombinant therapies in our industry. We have recently been awarded America's Best Employers for 2022 by Forbes magazine . We are offering this excellent opportunity to join CSL as Quality Compliance Manager. The Quality Compliance Manager will report to the Head of Site QualityResponsibilities:

  • Responsible for developing and implementing Quality Assurance Systems to ensure compliance with company standards and regulatory guidelines
  • Establishes and maintains GMP-related quality systems including standard operating procedures (SOPs) and supportive systems to ensure cGMP compliance
  • Defines procedures governing quality systems processes: document management, change control, deviation handling, product quality review, training, supplier qualification and audit management
  • Manages GMP and GQP systems for timely release of CSL products to the market
  • Ensures preparation, successful conduct and follow-up of all regulatory inspections, self inspections and customer audits
  • Provides technical guidance and recommends improvements to quality systems and processes
  • Drives continuous improvement through communication and training on quality standards, requirements, and best practicesEducation:
    • Bachelor's degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry); advanced degree preferredQualifications
      • 5-10 years' experience in quality/GMP in the pharmaceutical/biotech industry
        • Experience with regulatory authorities and international inspections
        • Experience within a global Matrix organization
        • Demonstrated success in project management and business/QA systems
        • Knowledge of appropriate regulatory requirements including GMP/GQP Our Benefits We encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL. About CSL Behring CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . We want CSL to reflect the world around us As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL. Do work that matters at CSL Behring!

Keywords: CSL Behring, Joliet , Senior Quality Compliance Manager, Executive , Kankakee, Illinois

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