Compliance Manager

Orano Projects Limited; Brownsburg (IN); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) matching

Paid time off

Job summary

Orano Med, a leading nuclear medicine entity, seeks a Compliance Manager, Quality Assurance for ATLAB-Indianapolis. You will drive the Quality Management System, ensure FDA/EMA/ICH/GMP compliance, and oversee audits, CAPA, and document control to enable timely, compliant production of radiopharmaceuticals.

The role requires extensive QA experience, leadership, and strong communication to coordinate cross-functional teams and regulatory readiness at a state-of-the-art facility.

Qualifications

• Bachelor’s degree in Chemistry, Engineering, or a related technical field.
• Minimum 5 years of progressive QA experience.
• 3+ years in a supervisory role in a regulated industry.
• Sterile injectable and radiopharmaceutical experience is a plus.
• Proficiency with document management systems and MS Office.
• Excellent written and verbal communication; ability to work independently and in a team.

Responsibilities

• Oversee the site Quality Management System (QMS) and electronic document system.
• Develop and monitor KPIs for quality metrics and support batch release.
• Manage document control and change management processes.
• Lead investigations of product complaints and material quality issues; oversee supplier quality.
• Lead internal audit programs across OranoMed sites; ensure audit readiness.
• Develop and execute CAPA program and effectiveness checks.
• Ensure completeness and compliance of documentation and annual product quality reports.
• Support regulatory inspections and provide required information to inspectors.

Skills

Quality Assurance

GMP

Document management

Audit management

Cross-functional teamwork

Education

Bachelor’s degree in Chemistry, Engineering, or related field

Tools

Microsoft Office

Job description

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.