Job Description
This a Full Remote job, the offer is available from: Europe The Manager of Quality Assurance is a quality professional within Linical responsible for assisting in the development and implementation of risk-based Good Clinical Practice oversight within Linical processes. This includes identification of risks, communication of risks to the organization, and working in a cross-functional team setting to mitigate the risks. Duties and Responsibilities • Support the Quality Assurance department in maintaining Linical’s Quality Management System (QMS) for all Linical services including: • Conduct of audits (systems, documents, TMF, clinical sites, vendors) • Follow-up of corrective and preventative actions (CAPA) and deviations • Supervision of SOP revisions • Review of SOPs in cooperation with the operational staff to ensure compliance with GCP and regulatory requirements • SOP-management (access control, notification of employees, tracking, etc.) • Vendor qualification and management of related documentation • Improving of standard and process for quality and efficiency • Computer system validation/verification • Provide support prior to and during regulatory inspections by authorities and audit performed by Sponsors on Linical • Consultancy for operational staff in quality, procedural, and regulatory related questions • Administrative tasks related to the maintenance of the QMS of Linical Required Skills and Abilities • Excellent command of written and spoken English • Ability to work independently and build strong, trusting working relationships with all departments and clients • Skilled in advising team on quality and compliance matters • Ability to familiarize oneself with specific indications, symptoms, and study designs • Very good knowledge of standard office software Education and Experience • University or college degree (or equivalent) in a medical or life-sciences related field • Minimum 8-10 years experience in clinical research according to GCP with at least 2 years in a Quality Assurance role within a GCP-regulated environment • Very good knowledge of GCP principles and related US, European, and other international regulatory requirements for the conduct of clinical trials • Practical auditing experience • Practical experience managing SOPs and the revision lifecycle This offer from "Linical" has been enriched by Jobgether.com and got a 81% flex score. Apply tot his job