Quality Assurance Lead - Therapeutic Radio-isotopes

Headline

Lead Quality Assurance as a new GMP Radioisotope Facility takes shape 

Highlights

• Design and implement a GMP-compliant quality system for the production of radioisotopes for targeted radiotherapy 
• Act as QA lead throughout project and operational phases, ensuring cross-functional support and compliance  

Job description

As part of its growing Targeted Radiotherapy programme, SCK CEN is developing a new GMP facility for radioisotope production. To support this effort, we are recruiting a QA Lead. 
During the project phase you will guide the development and implementation of a robust, GMP-compliant quality system.  
Your responsibilities include: 

• Design and implement pharmaceutical quality management system (QMS), including deviations, CAPAs, training, supplier qualification, and audits
• Ensure the implementation of the electronic quality management system in collaboration with external partners
• Draft and manage quality-related agreements with external stakeholders (e.g., Quality Technical Agreements) 
• Provide QA guidance on equipment, procedures, IT systems, validation activities, and review and approve documentation
• Act as QA responsible for the Nuclear Medical Applications institute at SCK CEN
• Align the pharmaceutical QMS with SCK CEN’s integrated management system
• Organize and oversee training for systems and processes within your scope

Once operations begin, your focus will shift to ensuring GMP compliance through ownership and execution of QA processes: 

• Manage QA processes such as deviation handling, CAPA follow-up, and change control
• Oversee execution of training programmes and maintain records of staff competencies
• Provide QA presence on the production floor to ensure GMP compliance during daily operations
• Maintain oversight of supplier-related quality matters and audit readiness

Job requirements

• Master’s degree in Industrial Pharmacy, Pharmaceutical Sciences, Bioengineering, or related field
• Minimum of 5 years' experience in a pharmaceutical QA role with progressive responsibilities
• Strong background in GMP compliance, with in-depth knowledge of national and international regulations 
• Official recognition as a Qualified Person (QP) is an asset and may lead to assignment as a backup QP
• Excellent communication, leadership and documentation skills
• Ability to work cross-functionally and independently in a multidisciplinary team
• A proactive, structured, and hands-on mindset
• Willing to work in controlled areas subject to radiation protection measures