Auditor - GLP

Main Responsibilities

• Cover assigned external audits of non-clinical facilities and safety laboratories.
• 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.
• 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.
• 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.
• Maintain up-to-date knowledge of global GLP regulations (ICH Safety Guidelines) 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.
• Knowledge: Directives 2004/9/EC and 2004/10/EC (GLP Directives), 21 CFR Part 58 – Good Laboratory Practice (GLP), OECD principles of GLP, ICH Safety Guidelines, ICH M3(R2) Guideline, ICH M10 Guideline.
• 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.