JobMesh

Quality Manager

TFS HealthScience · Frankfurt Am Main, Hesse, DE

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout...

Job description

About this role TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions. Working closely with the Head of Quality Management, you will contribute to the development of the overall quality strategy and play a key role in ensuring that clinical trial processes are conducted in a compliant, efficient, and scientifically robust manner. Key Responsibilities: - Advise project teams and internal functions on quality and compliance requirements, including applicable GxP standards, international guidelines, and regulatory expectations - Plan, coordinate, and support internal and external audits and inspections, including preparation, execution, documentation, and follow-up of findings - Conduct risk analyses across processes and studies, assess quality and compliance risks, and derive appropriate improvement measures - Support CAPA management activities, including root cause analysis, definition of corrective and preventive actions, and effectiveness...