Gcp QA Manager

Vor 3 Tagen


Basel, Schweiz Hobson Prior Vollzeit

Hobson Prior are currently seeking for a resourceful GCP QA Manager to join an exceptional biopharmaceutical establishment on a permanent basis located in Basel. Our client is focused on offering novelty solutions for rare illnesses.

Please note that to be considered for this role you must have the right to work in this location.

**Key Responsibilities**:

- In this role, you will be responsible for contributing to the monitoring and reporting of KPIs and metrics related to quality processes, and to the preparation and reporting of Quality Reviews.
- Responsible for reviewing and giving guidance to the development of clinical SOPs owned by R&D and Medical Affairs.
- You will 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.
- 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.
- 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.
- You will 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.

**Key Skills**:

- Strong individual initiative, organisational/people skills and multi-tasking abilities.
- For this role, you will need to be collaborative.
- Structured and detail oriented.

**Requirements**:

- Strong knowledge of applicable ICH GCP guidelines, industry best practices and regulatory requirements.
- Documented education/experience in QA systems and preferably auditing.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.


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