Orano USA ยท 3 weeks ago
Associate Director, Quality Assurance
Brownsburg, IN
Full-time
Onsite
Lead/Staff, Director/ExecutiveOrano USA is seeking an Associate Director, Quality to drive technical excellence and regulatory compliance at ATLab Indianapolis, a facility for sterile radiopharmaceutical manufacturing. The role involves overseeing quality assurance processes, ensuring compliance with GMP standards, and contributing to the timely delivery of life-saving therapies.
Utilities
Responsibilities
Provides daily oversight of the QA teams responsible for supporting all production/processing areas
Develops and monitors appropriate KPI's 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 regards to QA personnel
Directs investigations of product complaints and manufacturing discrepancies for manufactured products and ensures completion of appropriate documentation
Performs review of root-cause analysis and other problem-solving activities to identify effective corrective and preventative actions and appropriate effectiveness measures
Provides QA review and approval of Investigations, CAPAs, SOPs, Change Controls, and protocols/reports
Ensures completeness, accuracy and compliance of all documentation. Coordinates the preparation, review, and approval of the Annual Product Quality Reports and any established metrics / KPIs
Participates in Regulatory/FDA inspections and audits by providing information or expediting/obtaining information required by the inspectors/auditors
Schedules and conducts pre-inspection review of operations and follow-ups where corrective action is required
Qualification
Required
Experience in quality assurance within a GMP environment
Strong understanding of regulatory compliance and quality systems
Proven leadership skills in managing QA teams
Ability to develop and monitor KPIs for quality assurance processes
Experience in conducting investigations of product complaints and manufacturing discrepancies
Strong problem-solving skills, including root-cause analysis
Experience in reviewing and approving Investigations, CAPAs, SOPs, Change Controls, and protocols/reports
Excellent documentation skills ensuring completeness, accuracy, and compliance
Experience in preparing and reviewing Annual Product Quality Reports
Ability to participate in Regulatory/FDA inspections and audits
Strong communication skills to provide information to inspectors/auditors
Company
Orano USA
U.S. advanced reactor services, uranium enrichment, uranium sales, used nuclear fuel management, federal services, and nuclear medicine.
Founded in 2017
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase