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

Siemens Healthineers AG; Barcelona; On-site; EUR 120,000 - 160,000; Full time

Job summary

Siemens Healthineers AG is seeking an International Quality Lead for PET radiopharma projects across multiple sites worldwide, including France, Spain, UK, Germany and Italy.

You will provide QA oversight throughout the project lifecycle—from concept through validation and regulatory approval—ensuring GMP compliance and QbD integration.

Qualifications

• Lead international QA for PET radiopharma facilities across sites.
• Oversee QA through concept to handover including regulatory approvals.
• Incorporate GMP and quality-by-design in facility design and risk assessment.
• Provide CQV strategies for facilities, equipment, and systems.

Responsibilities

• Act as International Quality Lead for PET radiopharma facilities.
• Ensure QA oversight through design, construction, qualification, validation.
• Implement QbD principles and assess compliance risks early.
• Define CQV strategies for facilities, equipment, and systems.
• Review Validation Master Plans and change controls.

Skills

Quality leadership

GMP compliance

Validation expertise

CQV strategy

URS/DQ/FAT/SAT

Risk assessment

Aseptic processing

VHP technologies

Equipment qualification

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,