Quality Assurance Manager - Europe
Full-time
Home-based in EU
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