Quality Assurance Manager

2 weeks ago

Budapest, Budapest, Hungary Linical Full time €60,000 - €90,000 per year

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

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