Offer summary

Qualifications:

University or college degree in a medical or life-sciences related field., 8-10 years of experience in clinical research according to GCP, with at least 2 years in a Quality Assurance role., Strong knowledge of GCP principles and international regulatory requirements for clinical trials., Excellent command of written and spoken English, with good office software skills..

Key responsibilities:

Support the maintenance of Linical’s Quality Management System (QMS) for all services.

Conduct audits and follow up on corrective and preventative actions (CAPA).

Review and manage SOPs to ensure compliance with GCP and regulatory requirements.

Provide consultancy for operational staff on quality and regulatory matters.

Job description

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