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

Siemens Healthineers AG; Piemonte; On-site; EUR 110,000 - 150,000; Full time

Job summary

Siemens Healthineers AG in various locations across Europe seeks an International Quality Lead for PET radiopharmaceutical manufacturing facilities. You will provide quality oversight from concept to handover, integrating GMP, regulatory requirements, and Quality-by-Design principles.

The role covers validation strategies, documentation oversight, and equipment qualification across the Radiopharma network.

Qualifications

• Extensive experience in QA for pharmaceutical facilities, preferably radiopharma.
• Strong understanding of GMP, regulatory requirements, and quality systems.
• Experience with commissioning, qualification and validation in a manufacturing environment.

Responsibilities

• Act as International Quality Lead for PET radiopharma facilities and major upgrades.
• Provide quality oversight through design, construction, commissioning, validation and handover.
• Define CQV strategies including URS, DQ, FAT, SAT, IQ, OQ, PQ and GMP release activities.
• Review and approve Validation Master Plans, protocols, deviations and change controls.
• Serve as quality expert for aseptic processing and VHP technologies.
• Oversee selection and qualification of critical manufacturing and QC equipment.

Skills

Quality leadership

Regulatory awareness

Risk assessment

Quality-by-Design

Project lifecycle

Tools

CQV methodologies

Validation protocols

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,