Senior Quality and Compliance Auditor

Job Description: • As a technical expert in quality and compliance, the Senior Quality & Compliance Auditor plays a critical role in ensuring adherence to company policies, study protocols, GxP guidelines, and global regulatory requirements governing clinical research activities. • This position requires a deep understanding of regulatory frameworks and risk-based auditing methodologies to drive compliance, enhance quality standards, and mitigate organizational risks. Requirements: • Education: Honor's Bachelor (minimum) • Experience: 7-9 Years in Quality auditing function in a contract research organization (CRO), pharmaceutical, biotechnology, or related organization • Understanding compliance and risk management issues relating to clinical research, and strong understanding of research ethics and privacy • Previous experience leading a team is required • Strongly Preferred: Certified Auditor (ASQ, ISO, or equivalent) • Expertise in regulations and standards governing clinical research including ICH GCP, ISO 19011, EMA Guideline on Computerized Systems and Data Integrity in Clinical Trials, etc. • Advanced technical knowledge in global regulations and industry standards as they apply to clinical research, medical devices and pharmaceuticals and in the conduct of clinical study operations • Knowledgeable of medical imaging and clinical research industry regulations and standards • Experience working and collaborating in a cross-functional global team environment • Excellent verbal and written communication skills required to draft and author written documents/reports/presentations • Strong interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback • Ability to plan, organize, prioritize and manage workload independently • Adaptable to changing environments, able to think quickly, able to deal with ambiguity and learn new tasks applying routine knowledge • Superior analytical skills focusing on identifying potential compliance issues, investigating root causes, brainstorming and identifying alternatives and assessing the effectiveness of actions • Proven skills in interpreting, synthesizing, inferring, evaluating and extracting pertinent data to identify areas of risk, trends and aggregated issues Benefits: Apply Now Apply Now