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Execute global GCP audits of investigator sites, CROs, and internal processes to ensure clinical trial data integrity. Identify non-compliance trends and collaborate with stakeholders to implement corrective and preventive actions.
Requires a BS degree in biological science and at least 3 years of QA experience in a GCP environment, including 3 years of NMPA inspection experience. Professional fluency in Mandarin Chinese is required for APAC stakeholder management.
Quality in clinical development is a matter of operational resilience as much as regulatory mandate. This role serves as a GCP Auditor within our Research & Development Quality audit program, responsible for executing the global audit plan to ensure the accuracy of clinical trial data and compliance with legal and corporate standards. By conducting audits of our clinical investigator sites, external vendors, and internal trial management processes, you identify the findings and non-compliance trends that could impact the integrity of our clinical research. We are looking for an experienced auditor who can navigate complex clinical environments and work collaboratively with stakeholders to develop corrective actions that ensure long-term systemic stability.
Main Responsibilities
Audit Execution: Conduct assigned external audits of clinical investigator sites, Contract Research Organizations (CROs), E-System providers, and Institutional Review Boards (IRBs/ECs)
Reporting & Risk Categorization: Develop and issue comprehensive Audit Reports, categorizing findings by risk level and providing recommendations for corrective and preventive actions (CAPA) related to trial conduct and data integrity.
Trend Analysis: Identify non-compliance trends and systematic risks within the Clinical (GCP) discipline, communicating these findings to line management and clinical functional leads to ensure trial robustness.
Continuous Improvement: Support initiatives to improve standard operating procedures (SOPs) for audit conduct and partner with stakeholders to develop risk-based, compliant solutions for clinical trial management and monitoring.
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.
Position Qualifications & 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. 3+ years of Inspection experience with China’s National Medical Products Administration (NMPA; formerly CFDA) demonstrating a strong understanding of local inspection readiness and management within a GCP-regulated environment.
Audit & Inspection 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. Professional fluency in Mandarin Chinese (written and spoken) is required to effectively manage communications and negotiations with key Asia-Pacific (APAC) stakeholders and partners.
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.
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/.
For more information on CSL benefits visit How CSL Supports Your Well-being | 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
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.
CSL is a leading global biopharma company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our businesses, CSL Behring, CSL Seqirus, and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 29,000+ people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. See our community guidelines: https://bit.ly/3Bs17Ra
Offices: 655 Elizabeth St, Melbourne, Victoria 3000, AU · 1020 1st Ave, King of Prussia, PA 19406, US
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