Quality Lead – Facilities, Engineering & Validation (f/m/d)

Siemens Healthineers AG; Saint-Genis-Pouilly; On-site; EUR 120,000 - 180,000; Full time

Job summary

Siemens Healthineers AG Radiopharma seeks an International Quality Lead to oversee GMP-compliant projects for PET radiopharmaceutical facilities and expansions across the network.

You will drive Quality-by-Design, validate systems, and ensure regulatory readiness while coordinating with global teams on aseptic processing and VHP technologies.

Responsibilities

• Act as the International Quality Lead and Subject Matter Expert for new PET radiopharmaceutical facilities and major upgrades.
• Provide Quality oversight across the project lifecycle from design through validation and regulatory handover.
• Ensure GMP, quality and regulatory requirements are integrated via Quality-by-Design principles and risk assessments.
• Define CQV strategies for facilities, equipment, utilities, and manufacturing processes including IQ/OQ/PQ and GMP release.
• Review and approve Validation Master Plans, protocols, reports, deviations, and change controls.
• Serve as the Quality expert for aseptic processing and VHP technologies across the network.
• Provide oversight for selection and qualification of critical manufacturing and QC equipment (cyclotrons, hot cells, isolators, etc.).

Skills

Quality leadership

GMP expertise

CQV planning

Regulatory liaison

Risk assessment

Job description

Job Requirements

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. At Siemens Healthineers (SHS) Radiopharma, we are committed to driving sustainable progress through cutting-edge technology. We empower our customers by bridging the physical and digital worlds—enhancing the way we live, work, and move, today and for future generations.

As the global leader in the supply of positron emission tomography (PET) radiopharmaceuticals, SHS Radiopharma pioneered the commercial PET radiopharmacy model over 30 years ago—and continues to shape the future of molecular imaging.

Location

Saint-Genis-Pouilly (France), Lisses (France), Barcelona (Spain), Dunstable (United Kingdom), Munich (Germany) or Colleretto Giacosa (Italy).

Type of contract: Permanent

Your Role

• 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,