Global Quality Lead – PET Radiopharma, CQV & Validation

Siemens Healthineers AG; Dunstable; On-site; GBP 110,000 - 150,000; Full time

Job summary

Siemens Healthineers Radiopharma is seeking an International Quality Lead to oversee GMP-compliant QA across new PET radiopharmaceutical facilities, expansions, and major upgrades. You will drive CQV strategies and risk assessments from concept through validation, ensuring regulatory alignment and exceptional quality across the network.

You will lead aseptic processing initiatives, VHP technologies, and qualification of critical equipment, partnering with cross-functional teams to secure timely,

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,

Skills

Quality leadership

GMP experience

CQV strategies

Aseptic processing

VHP technologies

Regulatory compliance

Facility design

Tools

Cyclotrons

Target systems

Hot cells

Isolators

Synthesis modules

Dispensing systems

VHP/decontamination systems

Job description

Siemens Healthineers Radiopharma is seeking an International Quality Lead to oversee GMP-compliant QA across new PET radiopharmaceutical facilities, expansions, and major upgrades. You will drive CQV strategies and risk assessments from concept through validation, ensuring regulatory alignment and exceptional quality across the network.

You will lead aseptic processing initiatives, VHP technologies, and qualification of critical equipment, partnering with cross-functional teams to secure timely,