Senior Quality Assurance Manager Clinical Trials | Life Scientist (m/w/d)

Job Summary

This senior-level position at Profil, a renowned clinical research organization specializing in metabolic diseases, involves leading and refining the Quality Assurance function within a clinical research environment. You will be responsible for the end-to-end audit lifecycle, including planning and conducting internal and external audits to ensure strict compliance with GCP, ICH, and FDA regulations. Day-to-day activities include managing Deviation and CAPA processes, performing root cause analyses, and driving risk management strategies. You will also oversee the lifecycle of QA Standard Operating Procedures (SOPs) and provide training to cross-functional teams. What makes this role unique is the high level of autonomy and the opportunity to transition into a team lead function within an international setting. You will act as the primary QA contact for regulatory inspections and sponsor audits, collaborating closely with departments ranging from Data Management to Medical Writing to ensure the highest standards of clinical research quality.