Global Quality Lead, PET Radiopharma Manufacturing

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

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.