Quality Assurance - Delegate Qualified Person

About the role

Lilly is hiring a Delegate Qualified Person (QP) for its ELECTS QA and QP team in Belgium. The role covers QP tasks, PR&D QA duties and, where applicable, the final China release, working with the CSD, PR&D, the Global Quality Development Unit, Business Partners, CPs and Regulatory Affairs. It is a full-time position.

Key responsibilities

• Delegate QP tasks such as EP batch release, QP certification of FING material received at the EU Hub, approval of deviations, change controls, study/country additions, retest date extensions, complaints, redistribution and supply chain mapping records, and EU GMP equivalency confirmations
• Ensure clinical trial materials comply with EU and Belgian regulatory requirements and GMPs, and inform management of quality events that could affect product quality and compliance
• PR&D QA: take part in regulatory inspections, external audits of partners and audit readiness, ensure CAPA are in place and followed, manage retention and reference samples, and support collaborations, alliances and Expanded Access programs
• Perform the final China release where applicable, in line with the minimum experience requirement
• Follow health, safety and environmental requirements and maintain confidentiality

Required profile

• Scientific Master's degree in Pharmacy, Qualified Person
• Several years of experience in QA-QP tasks in the pharmaceutical environment
• Minimum 5 years of practical experience in drug R&D, production or quality management, with at least 1 year in drug quality management (for China release)

Required skills

• Thorough knowledge of EU and Belgian regulatory requirements, EU GMP/GDP and Lilly quality standards for clinical trial materials
• Knowledge of quality systems for deviations, change controls, complaints and CAPA
• Ability to perform QP certification and batch release decisions, and to audit and approve quality documentation
• Excellent written and verbal English, with the ability to escalate critical quality and regulatory issues

What we offer

• Anticipated wage of EUR 67,500 - 99,000, depending on education, experience, skills and location
• Possible company bonus for full-time equivalent employees
• Benefits including pension plan, vacation, healthcare, flexible benefits, life insurance and well-being programs