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