Global Quality Lead for PET Radiopharma Facilities

Siemens Healthineers AG; Paris; On-site; EUR 90,000 - 130,000; Full time

Job summary

Siemens Healthineers AG in France leads Radiopharma initiatives and seeks an International Quality Lead to oversee new PET radiopharmaceutical facilities and major expansions across the Radiopharma network. You will ensure GMP, regulatory and quality-by-design integration throughout concept, design, construction, commissioning and handover.

As the aseptic processing and VHP expert, you will review CQV strategies, qualification documents and validation plans, and provide oversight for critical

Responsibilities

• Act as the International Quality Lead and Subject Matter Expert for new PET radiopharmaceutical manufacturing facilities, facility expansions, new production lines, and major facility or equipment upgrade projects across the Radiopharma network.
• Provide Quality oversight throughout the entire project lifecycle, from concept and facility design through construction, commissioning, qualification, validation, regulatory approval, and operational handover.
• Ensure GMP, Quality, and regulatory requirements are integrated into facility and process design through Quality-by-Design principles, design reviews, and risk assessments, identifying and mitigating compliance risks at the earliest stages.
• Define and oversee Commissioning, Qualification & Validation (CQV) strategies for facilities, equipment, utilities, computerized systems, and manufacturing processes, including URS, DQ, FAT, SAT, IQ, OQ, PQ, process validation, and GMP release activities.
• Review and approve Validation Master Plans, protocols, reports, deviations, change controls, risk assessments, and all supporting qualification and validation documentation.
• Serve as the Quality expert for aseptic processing and Vaporized Hydrogen Peroxide (VHP) technologies, supporting system design, cycle development, qualification, validation, routine operations, performance monitoring, requalification activities, and contamination control strategies.
• Provide Quality oversight for the selection, qualification, and implementation of critical manufacturing and QC equipment, including cyclotrons, target systems, hot cells, isolators, synthesis modules, dispensing systems, VHP/decontamination systems,

Job description

Siemens Healthineers AG in France leads Radiopharma initiatives and seeks an International Quality Lead to oversee new PET radiopharmaceutical facilities and major expansions across the Radiopharma network. You will ensure GMP, regulatory and quality-by-design integration throughout concept, design, construction, commissioning and handover.

As the aseptic processing and VHP expert, you will review CQV strategies, qualification documents and validation plans, and provide oversight for critical