REDEFINING THE EXPERIENCE OF CANCER THROUGH OUR TRUSTED LEGACY IN NUCLEAR MEDICINE

At Curium, we have a singular focus – to develop, manufacture and supply world-class radiopharmaceutical products around the globe. We strive to innovate further in nuclear diagnostics and therapies so we can enhance the lives of people with cancer.
Every day we see the impact that our treatments offer and the potential they have to provide a world beyond cancer and other debilitating conditions. We continue to push boundaries and reach new heights in everything we do, supported by significant investment into new technologies and therapies.

SUMMARY OF POSITION

• Ensure compliance with Good Distribution Practice (GDP) regulations to maintain product quality and integrity throughout the supply chain.
• Implement, maintain, and oversee the Quality Management System to ensure systems, procedures, controls, risk management, and continuous improvement meet regulatory requirements for aspects relating to Quality Assurance, Regulatory Affairs, Pharmacovigilance, Product distribution and importation (as applicable).
• Manage quality events such as customer complaints, deviations, recalls, and returns, implementing CAPA as necessary.
• Lead/host and conduct internal and external audits and inspections, and provide training to uphold GDP standards and regulatory compliance.
• Assist in inspections by regulatory authorities.

EDUCATION:

• University degree in pharmacy or equivalent.
• Postgraduate degree in related subjects preferred, such as pharmaceutical technology or quality, though equivalent relevant experience will also be considered as important.
• Practical knowledge and training in current applicable pharmaceutical GxP requirements (eg. GVP, GMP, GDP) is a requirement.
• Formal training as a QMS Lead Pharma Auditor would be an asset but is not strictly necessary.
• Formal training as an EU Responsible Person (RP) or CZ/SK Qualified Person for Distribution would be very desirable.

EXPERIENCE:

• Minimum 5 years’ QMS or QA auditing, or other relevant work experience (eg. pharmacovigilance) in the Czech, Slovak, Netherlands or other European pharmaceutical and/or biotech industry.
• Leading and/or participating in GMP, GDP or GVP audits for the Czech, Slovak or wider European pharmaceutical industry.
• Knowledge of managing and setting up controlled document management systems as part of a pharmaceutical QMS.
• Minimum basic knowledge of the drug development process.
• Demonstrable knowledge of how Pharmacovigilance processes, GVP regulations and guidelines work in a pharmaceutical QMS.
• Personal direct involvement in receiving regulatory inspection (eg. SUKL, IGJ or EMA) is an asset.

PREFERRED SKILLS/QUALIFICATIONS:

• Fluency in written and spoken Czech and English is a requirement whilst knowledge of another European or international language (such as Spanish, French or Dutch), would be an asset.
• Good and effective interviewing, oral presentation, communication and other interpersonal skills.
• Personal flexibility and ability to frequently travel nationally or internationally up to 10-20% of the time.
• Excellent analytical, problem-solving and decision-making skills.
• Able to demonstrate responsibility, maturity and project leadership in a crisis.
• Capacity for independent, well-organized, correct and punctual work-delivery.
• Ability to follow strategy, changing direction rapidly if required in order to achieve quality objectives.
• Supervisory skills that allow the delivery of team tasks and objectives on time and as required.
• Intermediate to advanced computer and software skills (eg. SAP, MS Dynamics 365, MS Office) are required.

COUNTRY SPECIFIC REQUIREMENTS:

• The person must be an EU citizen and reside within a commutable distance of the Czech office in Prague.