Compliance Manager

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. Requirements Qualifications Bachelor’s degree in Chemistry, Engineering, or a related technical field. Experience Minimum of 5 years of progressive challenging experience in quality assurance. 3+ years as a supervisor or above, in pharmaceutical or related regulated industry Sterile injectable and radiopharmaceutical experience is a plus Strong attention to detail and organizational skills. Proficiency in document management systems and Microsoft Office Suite. Excellent written and verbal communication skills. Ability to work independently and collaboratively in a team environment. Benefits Competitive compensation Health, Dental, and Vision insurance – with generous employer contributions 401(k) with employer matching and contribution amounts Life insurance and Short- and Long-Term Disability insurance provided by the company Generous Paid Time Off and holiday schedules Numerous Training and Development opportunities and more… Present in the United States for 60 years, Orano USA is a leading technology and services provider to the U.S. commercial and federal markets. Orano’s activities in the U.S. include developing uranium enrichment facility in Oak Ridge, TN ; packages and transportation of uranium & nuclear fuel assemblies ; fabricating & installing used nuclear fuel dry storage canisters and casks, conducting pool-to-pad used nuclear fuel transfers ; providing solutions to the National Labs and to the Dept of Energy ; and supplying U.S. nuclear energy utilities with uranium, conversion, and enrichment services. In the nuclear medicine field, Orano Med is at the forefront of research in nuclear medicine and is developing a new generation of targeted therapies against cancer using the unique properties of lead-212. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. This position requires a pre-employment background check and drug screening. Orano is an Equal Opportunity Employer. Orano and all subsidiaries abide by applicable legal requirements. We ensure that all personnel actions such as recruitment, compensation, career development, benefits, and company-sponsored training are administered without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, protected veteran, or other protected status. #J-18808-Ljbffr Orano Projects Limited