Teams at WEP Clinical

Lead QA activities to ensure GxP/GMP/GDP compliance across pharmaceutical distribution and manufacturing. Oversee deviations, CAPAs, change controls, batch reviews, validations, audits, supplier qualification, recalls, documentation, and support client-facing supply projects to protect product quality and patient safety.

Manage setup, execution, and close-out of Post Approval Named Patient Programs (PA-NPP) and related expanded/compassionate access programs. Serve as central client/vendor contact, maintain CTMS/eTMF and study data, oversee supply chain shipments, lead meetings, support safety and QA activities, train staff, and manage program budgets and deliverables.

Provide GCP quality systems leadership for global clinical operations, overseeing decentralized trial activities, leading investigations and CAPAs, managing risk assessments, reviewing clinical/GCP documents, supporting audits/inspections and vendor qualification, driving QMS improvements, and mentoring QA staff to ensure regulatory compliance and continuous quality improvement.