ABOUT CURIUM

The Group Curium is the world’s largest nuclear medicine company with over 1 b € revenues. At Curium, we have a singular focus – to develop, manufacture and supply world-class radiopharmaceutical products around the globe. With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 15 million patients annually. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence, and unparalleled service.

Building on its unique strengths across radiopharmaceutical product manufacturing, logistics and commercialization, and led by an agile, LBO-driven leadership team, Curium has already achieved a critical mass and is the largest player in the nuclear medicines field. This is one that has become increasingly dynamic and innovative in recent years, in particular following Novartis’ acquisitions of Advanced Accelerator Applications and Endocyte.

Position Summary

The Qualified Person (QP) is responsible for ensuring the certification and release of radiopharmaceutical products in compliance with GMP requirements, regulatory standards, and marketing authorizations. This role oversees batch release activities, supports quality system compliance, manages regulatory documentation, and collaborates with cross-functional teams to ensure product quality, patient safety, and continuous regulatory adherence.

Responsibilities

Batch Certification & Release

• Lead and supervise all processes from production start to formal product release.
• Certify each batch of finished product prior to release, verifying all manufacturing and quality control records.
• Issue and archive batch conformity certificates in the official Batch Release Register.
• Ensure each batch is manufactured in accordance with marketing authorisation, regulatory standards, and approved documentation.

Quality System & Regulatory Compliance

• Approve and maintain manufacturing and batch documentation for the legally required retention period (minimum 5 years).
• Support inspections and ensure timely and effective Corrective and Preventive Actions (CAPA).
• Ensure ongoing compliance with quality standards, regulations, and updated legislation.
• Maintain confidentiality of all documents, data, and sensitive information.

Supplier & Material Compliance

• Ensure materials and services impacting product quality comply with approved standards.
• Support implementation of supplier quality assurance processes aligned with the company’s quality system.

Operational & Safety Responsibilities

• Collaborate with the Radiation Safety Officer to ensure production activities follow radiation safety protocols and emergency plans.
• Coordinate investigation and management of customer complaints with internal quality teams.
• Support implementation of an effective pharmaceutical quality management system in line with obligations of the marketing authorization holder.

Documentation & Reporting

• Prepare and approve SOPs, work instructions, technical agreements, specifications, validation documents, change controls, deviation reports, and complaint records.
• Report safety issues and product reactions to the Qualified Person Responsible for Pharmacovigilance (QPPV).
• Prepare and submit regulatory applications and notifications to national authorities; participate in inspections, renewals, and authorisation processes.

Qualifications

• Bachelor’s degree in Chemistry, Chemical Engineering, Pharmacy or related scientific discipline.
• Valid Qualified Person (QP) certification (Min 6 years experience).
• Minimum 2 years’ experience in the pharmaceutical or radiopharmaceutical industry.
• Strong knowledge of GMP and regulatory frameworks.
• Excellent command of Romanian and English.
• Residing in or able to commute to Bucharest.

We Offer

• Opportunity to join a well-recognized international group
• Competitive compensation package with performance-based incentives
• Opportunities for professional development and career growth
• A dynamic, collaborative, and supportive working environment
• Exposure to international best practices and cross-functional teamwork

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Equal Opportunity Employer

Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

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