Continuous Improvement: Support initiatives to improve standard operating procedures (SOPs) for audit conduct and partner with stakeholders to develop risk-based, compliant solutions that ensure compliance with EMA Guidelines on Good Pharmacovigilance Practices (GVP Modules), and applicable global and local regulatory requirements..
Regulatory Knowledge: Maintain up-to-date knowledge of global GVP regulations (Good Pharmacovigilance Practices) and industry trends, to support internal quality and compliance.
Position Qualifications & Experience
Academic Background: BS degree in a relevant biological science, pharmacy, or related science discipline.
Professional Experience: Quality Assurance experience within a GVP-regulated environment, demonstrating a strong understanding of drug safety operations and regulatory frameworks.
Audit Expertise: Experience in audit and inspection management, with a clear understanding of the requirements for quality assurance in the pharmacovigilance discipline.
Communication Skills: Excellent interpersonal and negotiation skills, with the ability to work effectively with multinational teams and external stakeholders across different regions.
Working Knowledge of
ICH E2D(R1), E2A, E2B(R3), E2C(R2), and E2F Guidelines
21 CFR Part 314.80 (for drugs), 21 CFR Part 600 Subpart D (for biologics) and 21 CFR Part 4 (Combination product/duplicate reporting prevention)
Directive 2001/83/EC (as amended)
Regulation (EC) No 726/2004
Commission Implementing Regulation (EU) No 520/2012
EMA GVP Modules (I–XVI + product/population-specific modules)
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.
