Plan and execute independent GCP audits (e.g., document audits, CRO/vendor audits, site audits, process audit, system audits, audits of critical data points) for clinical trials worldwide, including biosimilars., Provide expert consultancy on GCP requirements for in-licensing projects., Prepare, support, and assess risks for regulatory inspections and clinical studies., Develop and update SOPs while ensuring compliance with current regulations., Train internal QA colleagues and stakeholders on relevant regulations., Lead gap assessments and implement corrective actions to maintain quality standards.
