Delegate Qualified Person Clinical Supply Quality
Core
Act as the EU-certified Qualified Person (QP) to review and release clinical trial materials (synthetics, biotherapeutics, ATMPs) for safe delivery to patients.
Role type
Regulatory Qualified Person (QP) for Clinical Supply Quality
Builds
Clinical trial supply chains for innovative medicines
Domain
Pharmaceutical industry, Clinical Trials, Quality Assurance
Required skills
EU Qualified Person certification, Industrial Pharmacist degree, GMP/GDP knowledge, Batch release review, Deviation investigation, CAPA definition, Regulatory compliance, Risk assessment, Stakeholder collaboration, Process improvement
Preferred skills
Sterile manufacturing knowledge, cGMP/ICH guidelines expertise, Audit representation, Coaching operational teams, Continuous improvement, Problem solving
Technologies
GMP, GDP, ICH guidelines, QMS, SOP
Responsibilities
Review batch information and perform release activities within the IMP license; Advise teams on GMP/GDP/clinical-trial requirements; Guide investigations of deviations and complaints; Represent QA during Health Authority inspections; Implement sustainable quality system improvements.
Seniority
Mid-Senior, hands-on regulatory expert