Orano Med, a subsidiary of Orano USA, is at the forefront of research in nuclear medicine and is developing new therapies against cancer. Based on its unique expertise in the extraction and purification of lead-212 (Pb-212) and radiolabeling technologies, Orano Med is developing innovative Pb-212-based treatments which consist of selectively destroying cancer cells while limiting the impact on surrounding healthy cells.
With a solid portfolio of development projects covering a diverse range of biological molecules capable of recognizing and targeting various forms of cancerous tumors, and a reliable supply chain for Pb-212, Orano Med aims to become a leader in targeted alpha therapies, in particular addressing needs of patients currently without effective therapeutic solutions among the existing approaches.
Position Summary
The Compliance Manager, Quality Assurance will be responsible for the development, maintenance, monitoring, and continuous improvement of the Quality Management System (QMS) at ATLAB-Indianapolis, a next-generation commercial-scale facility for sterile radiopharmaceutical manufacturing. This position plays a critical cross-functional role in ensuring site readiness and ongoing compliance with FDA, EMA, ICH, and applicable GMP requirements through effective management of quality systems, inspection readiness programs, audits, metrics, training governance, and continuous improvement activities. This role will provide site oversight contributing directly to the timely and compliant delivery of life-saving therapies.
Key Responsibilities
- Provides daily oversight and ownership of the site Quality Management System (including the electronic document system).
- Develops, compiles and monitors appropriate KPI’s for site quality metrics, including quality trends, Right First Time (RFT), record closure turnarounds, and support of timely batch release. Presents KPIs at quarterly management reviews.
- Develop and manage document control processes and change management.
- Directs investigations of product complaints, raw material quality issues, and system-related discrepancies. General responsibility for all supplier quality oversight.
- Develops and executes internal audit program for multiple OranoMed sites (cross-site responsibility).
- Develops and executes site CAPA program and change management program, along with all required effectiveness checks.
- Ensures completeness, accuracy and compliance with all documentation. Coordinates the preparation, review, and approval of the Annual Product Quality Reports and any established metric/ KPIs.
- Participates in Regulatory/FDA inspections and audits by providing information or expediting/ obtaining information required by the inspectors/auditors.
- Develops and manages the site data integrity program.
