**Description of The Position**
The Senior Specialist, Quality Assurance Auditor, ensures quality and compliance with local and international regulatory requirements by conducting internal and external audits.
This role provides guidance to internal stakeholders, assisting in the establishment of the company's compliance strategy and the resolution and prevention of compliance risks.
**Responsibilities**
- Evaluate Organon systems, processes, Affiliates, Vendors, Business Partners, and Investigator sites for compliance with regulatory requirements.
- Schedule and conduct GVP/GCP audits in accordance with the global audit plan ensuring compliance with local and international guidelines and regulations.
- Prepare audit reports and manage follow-up activities with limited guidance.
- Conduct meetings with Senior Management to discuss audit observations and responses.
- Supports the implementation and maintenance of the GVP/GCP risk-based strategy, includ...