Quality Assurance Compliance Manager

1 week ago

Melbourne, Victoria, Australia beBeeCompliance Full time $120,000 - $160,000
Job Description

We are seeking a highly skilled professional to manage our quality assurance compliance programs.

  • Lead and coordinate quality initiatives and taskforces as they arise from different sources and issues.
  • Initiate and manage impact assessments of new regulatory requirements, ensuring compliance with global policies.
  • Manage all Corrective and Preventive Actions (CAPA) resulting from the Regulatory Alert impact assessments and provide reports as part of the Quality Management Review Process.
  • Mentor and develop team members to provide support across the site to ensure compliance with regulatory requirements and global policies.
Requirements and Qualifications

To be considered for this role, you should have:

  • A degree in science or engineering, or pharmaceutical science.
  • 5+ years' experience in the pharmaceutical manufacturing industry in a cGxP environment.
  • Experience with cGxP regulatory requirements including industry guidance documents such as those required by TGA or FDA.
  • Experience leading a technical team in a regulated environment and providing technical support.
  • Experience preparing written technical documents and presenting complex information.
  • Experience in a role requiring conceptual and analytical thinking to reconcile ambiguities.
Benefits

As an employee at CSL Behring, you will have access to a comprehensive benefits package that includes:

  • Health and wellness programs to support your physical and mental well-being.
  • Professional development opportunities to help you advance your career.
  • A competitive salary and bonus structure.
About Us

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.

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