Nancy Berger

Associate Director, R & d Training Lead, R & d Process and Training @Jazz Pharmaceuticals

Palo Alto, CA, US

Independently oversees the implementation of integrated and comprehensive data-driven Quality Monitoring activities to ensure compliance with regulatory requirements and SOPs, and to ensure a continued state of inspection readiness. Develop and chair cross-functional SOP governance committee. Manages OE team activities effectively to accomplish agreed upon deliverables within the timeframe established, including but not limited to review and assessment of Quality Risk Management metrics and implementation of corrective actions, review and planning of submission activities, review of clinical activities to ensure ongoing inspection readiness, coordination of CAPA activities for investigator audits/regulatory authority inspection activities, and vendor qualification assessments and quality reviews of key clinical trial documents. Works in a collaborative manner with business partners to create a team environment that addresses compliance-related issues and corrective actions that meet the business needs on an on-going basis.

University of Colorado Denver

B.S.N, Nursing