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Quality Assurance Manager

Linical
London
1 month ago
Applications closed

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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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