About this role
At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve.
This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. Main Purpose and Objectives of Position: As a member of ELECTS QA and QP team, this position is responsible for: - Delegate Qualified Person tasks listed below - Assume PR&D QA tasks as listed below - Ensure compliance with EU and Belgian regulatory requirements, GMP/GDP and Lilly standards of activities performed on behalf of ELECTS and Lilly - Working with the CSD and PR&D functions as well as key members of the Global Quality Development Unit, Business Partners, CPs and Regulatory Affairs - Contributing to the realization of the Quality Objectives in connection with the GMP’s activities of PR&D. - Supporting activities performed by ELECTS QA and Lilly PR&D QA groups - Perform the Final China release, as applicable depending on seniority (Min 5 years of practical experience in Drug R&D or Drug Production and Quality Management with min 1 year in Drug Quality Management) Key Responsibilities 1.
Delegate Qualified Person Delegate Qualified Person (QP), performing following actions (but not limited to): - EP (Extemporaneous Preparations) batch release - QP certification for FING material received at EU Hub - Owner, assessor, investigator and/or approver of deviations and change controls - Ensure Clinical Trial material is compliant with EU and Belgian regulatory requirements and GMPs, product specification file, the CM&C information approved by the Authorities of the relevant countries - Approval of extension of retest date - Approval of study/country addition - Issue Bio API certification documentation - Participate in the regular review of global and local quality metrics for GMP/GDP activities including deviation - Inform QP and Management of all quality events that could impact product quality and compliance - Perform QP oversight on activities linked to the responsibilities of the ELECTS QP - Lead and participate in different actions and projects impacting ELECTS QA and QP - EU GMP equivalency confirmation issuance - Approval of QP Declaration - Approval of complaints - Approval of redistribution - Approval of Execution of Supply Chain Mapping Record - Approval of Study Level Product Maps when needed 2. PR&D QA functions - Interact with all the quality organizations (GQAAC, QA, Corporate, Regulatory); - Participate in Regulatory inspections; - Take part of external audits of Collaboration Partners and Alliance Partners; - Assist or act as an auditor for Self Inspection; - Participate in the audit readiness; - Ensure on time notification of critical quality and regulatory issues to management and asses any relevant communication to authorities; - Ensure that CAPA are in place, are followed and efficient. - Ensure adequate management of Retention and Reference samples at EU Hub; - Assist in products retrieval coordination; - Provide support for collaborations and alliances with external partners, as well as for Expanded Access Programs. 3.
Final China Release - Perform the final Release for China according to art. 9 of China regulations prior to site distribution in China, as applicable. Note: This activity is only applicable for individuals meeting the expectations of the regulation as documented in the Quality System (e.g.
Minimum 5 years of practical experience in Drug R&D or Drug Production and Quality Management with a minimum of 1 year in Drug Quality Management) 4. Health, Safety and Environment - Carry out the activities in accordance with company and site safety and environmental requirements. 5.
Confidentiality - Ensure that confidential information remains confidential. 6. Quality Culture - Make quality culture the foundation of your work, to ensure our products are safe and effective to im-prove patients’ lives. - Maintain ownership and emphasis on quality, ensuring quality in all daily activities. - Demonstrate engagement and employ a quality mindset in all endeavours by proactively identifying quality issues and communicate appropriately.
Backup: ELECTS QP Delegate Team Profile Scientific Master’s Degree in Pharmacy, Qualified Person Min. several years of experience in QA-QP tasks within the pharmaceutical environment Thorough knowledge of EU and Belgian regulatory requirements, EU GMP/GDP and Lilly quality standards applicable to clinical trial materials Knowledge of quality systems for deviations, change controls, complaints and CAPA management Familiarity with regulatory inspections, audit readiness and self-inspection processes Ability to perform QP certification and batch release decisions, and to assess and approve quality events based on risk Strong analytical and investigative skills, with the ability to own, assess and approve deviations and change controls Ability to review and approve quality documentation accurately (e.g. QP declarations, EU GMP equivalency confirmations, supply chain mapping records, study level product maps) Ability to audit and assess external collaboration and alliance partners Excellent written and verbal communication in English, including timely escalation of critical quality and regulatory issues to management Strong quality mindset and ownership of quality in all daily activities, in line with Lilly quality culture Collaborative approach Ability to prioritise and manage multiple activities and projects in a deadline-driven environment Proactive, with the ability to lead and contribute to improvement actions and projects Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance.
Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.
The anticipated wage for this position is €67,500 - €99,000 Full-time equivalent employees may also be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a pension plan; vacation benefits; eligibility for healthcare benefits; flexible benefits (if applicable) life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly