To provide QA support and quality oversight to the clinical organisation within R&D and Medical Affairs in compliance with applicable GxP requirements.
This position will be based in Sweden or in Switzerland.
Within Global GxP Compliance & Quality Systems department, provide active support in the development and continuous improvement of the Quality Management System and related documentation system, as appropriate.
Contribute to the monitoring and reporting of KPIs and metrics related to quality processes, and to the preparation and reporting of Quality Reviews.
Act as QA representative in the department Global GxP Compliance & Quality Systems, for operational teams and support functions (e.g. represent QA in team meetings or project-specific meetings) within the R&D and Medical Affairs organization
To review and give guidance to the development of clinical SOPs owned by R&D and Medical Affairs.
To review and give guidance to the development of SOPs in relation to Investigator Sponsored Studies (ISS) and Market Access Programs (MAP).
To collaborate with QP IMP and review and give guidance in relation to IMP management and Quality agreements to ensure GCP compliance.
Act as Quality approver of clinical and ISS/MAP SOPs owned by R&D and Medical Affairs.
Actively contribute to problem solving, give support to operational teams and support functions as regard to quality related issues.
Degree in life science (pharmacy, biological sciences, chemistry, or related field).
Minimum 5 years active broad experience in Clinical Quality Assurance or in the operational conduct of clinical trials and the application of GCP.
Good knowledge of applicable ICH GCP guidelines, industry best practices and regulatory requirements.
Excellent understanding of QA procedures and application in the daily work
Documented education/experience in QA systems and preferably auditing