Quality in preclinical development is a matter of operational resilience as much as regulatory mandate. This role serves as a GLP Auditor within our Research & Development Quality audit program, responsible for executing the global audit plan to ensure the accuracy of non-clinical safety/toxicology studies trial data and compliance with legal and corporate standards. By conducting audits of our external vendors (GLRP, GLP and GcLP) and internal trial management processes, you identify the findings and non-compliance trends that could impact the integrity of our non-clinical research. We are looking for an experienced auditor who can navigate complex pre-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 non-clinical facilities and safety laboratories.
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 Non-clinical (GRLP/GLP/GCLP) 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 non-clinical trial management.
Regulatory Knowledge: Maintain up-to-date knowledge of global GLP regulations (ICH Safety Guidleines) and industry trends, identifying new requirements to ensure a high level of quality is maintained across all non-clinical development programs.
Position Qualifications & Experience:
Academic Background: BS degree in relevant biological science, science, or related discipline
Professional Experience: 3+ years of Quality Assurance experience within a pre-clinical and safety laboratory environment, demonstrating a strong understanding of preclinical trials, monitoring, and regulatory frameworks.
Audit Expertise: Experience in preclinical audit and inspection management, with a clear understanding of the requirements for quality assurance in the preclinical research discipline.
Communication Skills: Excellent interpersonal and negotiation skills, with the ability to work effectively with external vendors providing relevant services.
Working Knowledge of:
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.
