Clinical Quality Assurance Specialist

ABOUT CURIUM

The Group Curium is the world’s largest nuclear medicine company with over 700 M € 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 14 million patients annually. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence, and unparalleled service. As a fast-growing company in a niche market, Curium is today owned by a private equity fund with LBO financing scheme.

SUMMARY OF POSITION

We are seeking a Clinical Quality Specialist to join our dynamic Quality Assurance (QA) team. This pivotal role ensures that our clinical practices meet the highest standards of quality, compliance, and continuous improvement. You will work collaboratively across teams—such as Clinical Operations and Clinical Development—to monitor processes, lead quality initiatives, and uphold regulatory standards.

If you are a proactive problem-solver with a passion for quality and excellence, we want to hear from you!

Note that the position can be fully remote from Italy, France, Spain, the UK, or Czech Republic.

KEY RESPONSIBILITIES

1. Quality Oversight & Compliance

• Monitor clinical trials and processes to ensure compliance with regulatory requirements and industry standards.
• Conduct audits of clinical documentation, investigator sites, vendors, and systems.
• Communicate compliance risks to senior management and support responses to regulatory inspections.

2. Process Improvement & Data Analysis

• Analyze quality data to identify trends and areas for improvement.
• Lead root cause analyses and implement corrective and preventive action plans.
• Develop and monitor quality metrics to support continuous improvement initiatives.

3. Training & Collaboration

• Provide training to clinical teams on quality processes and compliance requirements.
• Collaborate with internal and external stakeholders to align quality strategies with organizational goals.
• Promote a culture of quality awareness and improvement across the organization.

4. Documentation & Reporting

• Maintain quality management databases and prepare reports on quality performance.
• Ensure timely documentation of clinical policies, procedures, and regulatory submissions.
• Support electronic health record implementation and manage clinical quality systems (e.g., VEEVA TMF).

REQUIREMENTS

Education and Experience(s)

• Bachelor's degree in healthcare administration, nursing, or a related field.
• Minimum of 3 years in clinical quality management, including experience with audits and regulatory inspections.

Required skills / hard skills

• Proficiency in data analysis, electronic health records (e.g., VEEVA TMF), and quality management systems.
• Regulatory Knowledge: Strong understanding of industry standards, compliance requirements, and guidance documents.

Preferred skills / Soft skills

• Exceptional communication, problem-solving, and organizational abilities; adept at managing multiple priorities.
• Experience in handling confidential information, fostering teamwork, and participating in professional development activities.

Ready to Make an Impact? Apply now to take the next step in your clinical quality career!

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.