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Responsibilities
- Under general supervision, supports Clinical Quality Assurance CQA programs for the assigned therapeutic and compliance area
- Completes audits to assess quality of scientific data and ensure compliance with relevant guidelines, legal requirements and GCPs etc.
- Provides guidance on applicable GXPs and compliance related issues and questions
- Supports management in reporting metrics, identifying trends, and evaluating the effectiveness of completed CAPAs to drive continuous improvement
- Develops and maintains procedural documents (SOPs) and tools to ensure regulatory compliance and consistency across Global R&D Quality/Global CQA
Qualifications
- University degree (BSc/MSc) in scientific discipline/life sciences or related discipline
- 3+ years' experience in a pharmaceutical company or clinical research organization
- Knowledge of Good Clinical and Good Laboratory and Quality Management System
- Knowledge of drug development process and international and national regulations
Note: Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
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About CSL Behring
CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
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Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging.
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
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