Senior Quality Assurance Specialist
About The Position
Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline ‘Life Forward’ represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.
Requirements
- Third level qualification in a scientific discipline – pharmacy, medicine, physics, chemistry, pharmaceutical chemistry and biology
- Minimum 5 years’ QA experience within a licensed environment
Responsibilities
- Maintain the QMS for PET radiopharmaceutical production
- Ensure compliance with GMP, HPRA, EPA, and Curium requirements
- Translate regulatory standards into SOPs and controlled documents
- Manage deviations, complaints, OOS/OOT, change controls, and CAPAs
- Track KPIs and drive continuous improvement
- Review and approve key quality documents
- Lead quality input for new products and technologies
- Support change control, tech transfer, and global initiatives
- Monitor, investigate, and close complaints promptly
- Support product recall and withdrawal processes
- Oversee validation lifecycle and ensure compliance
- Maintain validated, controlled processes
- Ensure timely release of 18F products
- Work with production and QC on controls and specifications
- Plan and conduct internal, supplier, and regulatory audits
- Manage inspection responses and follow-ups
- Ensure systems comply with Annex 11 requirements
- Provide and participate in GMP and quality training
- Communicate supply issues in a timely manner
- Support compliance with GVP requirements
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What This Job Offers
Job Type
Full-time
Career Level
Senior
