Associate Director, Quality Assurance

Associate Director, Quality Assurance

Orano USA – Associate Director, Quality will be responsible for driving technical excellence and regulatory compliance at ATLab Indianapolis, a next‑generation commercial‑scale facility for sterile radiopharmaceutical manufacturing. This position plays a critical cross‑functional role in ensuring the facility operates with maximum reliability, safety, and regulatory readiness, contributing directly to the timely and compliant delivery of life‑saving therapies.

The Associate Director, Quality supports the company’s short‑ and long‑term goals for maintaining Quality Systems and Compliance. This position provides direct oversight for the evaluation, implementation, execution and follow‑up on quality systems in support of GMP compliance and release of finished product. This role oversees quality assurance of the manufacturing and packaging processes and procedures, the final review of investigations, and appropriate implementation of corrective actions to prevent recurrence.

• Provide daily oversight of the QA teams responsible for supporting all production/processing areas.
• Develop and monitor appropriate KPIs for batch documentation review, Right First Time (RFT) and support of timely batch release.
• Responsible for department resource planning, talent development, and budget administration with regard to QA personnel.
• Direct investigations of product complaints and manufacturing discrepancies for manufactured products and ensure completion of appropriate documentation.
• Perform review of root‑cause analysis and other problem‑solving activities to identify effective corrective and preventative actions and appropriate effectiveness measures.
• Provide QA review and approval of Investigations, CAPAs, SOPs, Change Controls, and protocols/reports.
• Ensure completeness, accuracy and compliance of all documentation.
• Coordinate the preparation, review, and approval of the Annual Product Quality Reports and any established metrics / KPIs.
• Participate in Regulatory/FDA inspections and audits by providing information or expediting/obtaining information required by the inspectors/auditors.
• Schedule and conduct pre‑inspection review of operations and follow‑ups where corrective action is required.

Mid‑Senior level

Full‑time

Quality Assurance

Nuclear Electric Power Generation