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Full-time
bachelor degree, postgraduate degree
Posted 4d ago
~40 hrs/week
Responsibilities
Supports Clinical Quality Assurance programs by conducting audits to ensure scientific data quality and compliance with legal requirements and GCPs. Develops procedural documents and monitors CAPA effectiveness to drive continuous improvement in Global R&D Quality.
Requirements
Requires a university degree in a scientific or life sciences discipline and at least 3 years of experience in a pharmaceutical company or CRO. Must possess knowledge of Good Clinical/Laboratory practices and international drug development regulations.
Full job description
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.
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.
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.
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.
Related keywords
CQAGCPGXPQuality Management SystemCAPASOPPharmaceuticalClinical Research OrganizationBiotherapeuticsRegulatory ComplianceLife SciencesAuditingDrug Development
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
Complex biologicalsvaccinesplasma and plasma derived therapeuticsbiotechnologyand biopharmaHealth DiagnosticsHealth CareBiotechnologyMedical
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
Complex biologicalsvaccinesplasma and plasma derived therapeuticsbiotechnologyand biopharmaHealth DiagnosticsHealth CareBiotechnologyMedical