Regulatory Knowledge: Maintain up-to-date knowledge of global GCP regulations (ICH E6) and industry trends, identifying new requirements to ensure a high level of quality is maintained across all clinical development programs.
Skills and Experience
Academic Background: BS degree in a relevant biological science, science, or related discipline
Professional Experience: 3+ years of Quality Assurance experience within a GCP-regulated environment, demonstrating a strong understanding of clinical trial phases, monitoring, and regulatory frameworks.
Audit Expertise: Experience in clinical audit and inspection management, with a clear understanding of the requirements for quality assurance in the clinical research discipline.
Communication Skills: Excellent interpersonal and negotiation skills, with the ability to work effectively with multinational clinical teams, investigators, and external CROs.
Working Knowledge of
ICH E6 (R3) Guideline
21 CFR Part 11 – Electronic Records; Electronic Signatures
21 CFR Part 50 – Protection of Human Subjects (Informed Consent)
21 CFR Part 312 – Investigational New Drug Application
21 CFR Part 812 – Investigational Device Exemptions
Clinical Trials Regulation (CTR) (EU) No 536/2014
Directive 2001/20/EC (Clinical Trial Directive)
Directive 2005/28/EC (GCP Directive)
Directive 2001/83/EC (Annex I)
Organizational Agility: Strong analytical and problem-solving skills, with the ability to work with limited supervision and manage a schedule that includes up to 50% travel.
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/.
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.
