Auditor – CQA Job at Maidenhead Full Time NEW

Quality in clinical development is a matter of operational resilience as much as regulatory mandate. This role serves as a CQA 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:

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. Organizational Agility:
Strong analytical and problem-solving skills, with the ability to work with limited supervision and manage a schedule that includes upto 50% global travel. About CSL Seqirus CSL Seqirus is part ofCSL. As one of the largest influenza vaccine providers in the world, CSL Seqirusis a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness.

With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit  and CSL Plasma at  . Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL .

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To learn more about inclusion and belonging visit  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  . Watch our On the Front Line video to learn more about CSL Seqirus