Quality Assurance

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