Director, Data Management: Quality & Inspection Readiness

Regeneron Pharmaceuticals, Inc.; Cambridge; Presencial; GBP 134.000 - 209.000; Jornada completa

Descripción de la vacante

Regeneron Pharmaceuticals, Inc. is seeking a Director of Data Management Quality and Inspection Readiness to provide strategic leadership for data management quality, compliance, and process excellence.

You will own quality frameworks, CAPA, and inspection readiness, coordinating with CROs and stakeholders to ensure regulatory readiness and adherence to global standards. The role includes developing governance for data management processes, training programs, and KPI/KQI frameworks to drive

Formación

• Experience leading data management quality programs.
• Strong knowledge of GCP, ICH guidelines, and global regulatory requirements.
• Ability to manage inspection readiness and regulatory inspections.

Responsabilidades

• Provide strategic leadership for Data Management quality and compliance.
• Develop quality frameworks and oversight processes for proactive issue management and CAPA.
• Lead inspection readiness activities and health authority inspections coordination.
• Establish training frameworks and KPI/KQI metrics for data quality and compliance.

Descripción del empleo

Regeneron Pharmaceuticals, Inc. is seeking a Director of Data Management Quality and Inspection Readiness to provide strategic leadership for data management quality, compliance, and process excellence.

You will own quality frameworks, CAPA, and inspection readiness, coordinating with CROs and stakeholders to ensure regulatory readiness and adherence to global standards. The role includes developing governance for data management processes, training programs, and KPI/KQI frameworks to drive