Aug 13, 2022
Title: Senior Manager, Clinical Quality Assurance Location: Gaithersburg MD 20878 and Remote BUT needs to be drivable to office Schedule: Standard busienss hours Type: Direct-Hire Start date: Immediately Responsibilities: Participates in oversight and management of Investigator Site Audits, Internal Audit and Clinical Vendors/CROs Quality Programs with guidance from management Works with internal and external GCP/PV entities and develop and execute strategic audit plans. Supports the development and/or review of GCP/PV audit agendas, audit plans, audit reports, and CAPA's for internal & external audits. Supports the development, implementation and maintenance of CQA systems and SOPs for GCP/PV systems Leads internal and external audits of the various quality elements to ensure compliance to GCP/PV/GCLP regulatory commitments and requirements, industry best practices and guidance Act as a contact with members of Regulatory Authorities and / or...
System One
Gaithersburg, MD, United States
Full time