Led the Consumer quality organization for Good Clinical Practice(GCP), Good Laboratory practice (GLP), Pharmacovigilance, and Cosmetovigilance.
Set the strategic direction for and provide oversight of global external outreach and stakeholder engagement across drug, device, and consumer sectors for BIoResearch Quality and Compliance. Led global advocacy, policy and external outreach efforts related to effective, efficient, and innovative clinical development and quality and compliance programs. Responsible for establishing the global strategic risk management vision and risk management policies, standards and procedures for BRQC. Drove the implementation of enterprise risk management across sectors.
While working at Jansen, managed team responsible for developing and implementing risk-based strategies and associated audit plans to ensure that trial, program, and clinical system-related risks are proactively identified and managed. Advised on complex compliance and quality issues. Lead Quality & Compliance – Pharma Risk Management Framework development and foster consistent integration of risk management framework. Led external quality innovation and outreach collaborations supporting the R&D Q&C – Pharma mission, including CTTI Quality-by-Design project.