Liane Wittlin

•Design and implement risk-based audit and quality oversight strategy covering the affiliates in assigned region. • Perform risk assessment to deliver the annual Affiliate audit program and/or risk mitigation activities. •Analyse data/metrics from audits, inspections and risk management activities for compliance trends and provision of periodic updates to the stakeholders.

• Performed audits globally, across all therapeutic areas and study phases, including audits at the GCP/GMP interface (IMP warehouse). Audit experience includes: Investigator sites, Clinical Pharmacology Units, Affiliate Country Operations (PD/PA), CROs, Central Laboratories, and Ethics Committees.

Planned, coordinated, organized and administered the different aspects of the clinical research & development activities of a clinical study / clinical project from study start-up through compilation of a New Drug Application (NDA), including logistics (IMP, material, equipment),