At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

REQUIREMENTS:

• Scientific Bachelor or Master degree
• 3 years of pharmaceutical experience, preferably in Clinical Trials and/or Quality
• Can work virtually
• Experience in subcontractors oversight
• Strong communication skills
• Must speak and write fluent English
• Problem solver and team player
• Knowledge of regulatory requirements and GMP/GDP
  Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.
  

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1. Collaboration Partners Qualification and Oversight

• Establish and maintain Quality Agreements and related working instructions, and Qualification Package between ELECTS and External Parties.
• Prepare and maintain quarterly performance data and the associated score cards for external partners.
• Ensure Quality oversight of the distributions and courier operations performed by External Parties and GMP Service Providers (as applicable).
• Assess and review all external deviation and change control issued by external partners.
• Maintain appropriate metrics with the different external partners.
• Review External Parties and local metrics to identify trends and work on a CAPA plan in order to solve identified trends.
• Act as point of contact to help solving all compliance/oversight issues that could arise with external partners.
• Act as point of contact for Global Quality Audit and Compliance Group (GQAAC) to prepare and support External Parties Audit.
• Track and monitor all actions GQAAC audits related to external partners including depots and couriers

MAIN PURPOSE AND OBJECTIVES OF POSITION:

As a member of the ELECTS quality team, this position is responsible for:

• The qualification and qualification oversight of the depots, HUBS and couriers used in the Clinical Trial material supply chain as applicable.
• The Quality operational support of the Clinical Trial (CT) logistics operations performed by HUB, depot and couriers and their conformity with the Lilly Corporate standards local procedures, national and international regulatory requirements and cGMPs and cGDPs.
• Supporting the day-to-day QA Logistics operations and becoming a Subject Matter Expert involved in problem solving, prioritization of workload and training of newcomers.
• Acting as a backup for the QA Logistics Coordinator as well as the Advisor QA – Global Qualification and Quality Support when they are unavailable.
• Acting as the ELECTS Samples process owner.
• Ensuring compliance with EU and Belgian regulatory requirements, GDP/GMP and Lilly standards of activities performed on behalf of ELECTS and Lilly.

KEY RESPONSIBILITIES:

1. Collaboration Partners Qualification and Oversight

• Establish and maintain Quality Agreements and related working instructions, and Qualification Package between ELECTS and External Parties.
• Prepare and maintain quarterly performance data and the associated score cards for external partners.
• Ensure Quality oversight of the distributions and courier operations performed by External Parties and GMP Service Providers (as applicable).
• Assess and review all external deviation and change control issued by external partners.
• Maintain appropriate metrics with the different external partners.
• Review External Parties and local metrics to identify trends and work on a CAPA plan in order to solve identified trends.
• Act as point of contact to help solving all compliance/oversight issues that could arise with external partners.
• Act as point of contact for Global Quality Audit and Compliance Group (GQAAC) to prepare and support External Parties Audit.
• Track and monitor all actions GQAAC audits related to external partners including depots and couriers.

1. Oversight of QA logistics daily operations

• Support QA logistics team in the resolution of operational issues related to external partners.
• Act as point of contact for operational issues escalations.

1. Backup of the QA Logistics coordinator and the Advisor QA – Global Qualification and Quality Support when needed

2. Samples Process Owner

• Act as the process owner for the sample management in ELECTS.
• Lead resolution of issues related to samples.
• Create and maintain the working instructions related to samples management.
• Lead the annual Reserve sample inspection (RIB), review and destruction (if applicable) of samples stored at External Parties.

1. Observations, Deviations and Change controls

• Create/assess/investigate/approve observations/deviations related activities handled by ELECTS.
• Create/review/approves Change Controls related activities handled by ELECTS.

1. Documentation

• Ensure documentation produced is handled and stored in compliance with our Quality System Requirement.
• Issue or review Standards/SOP/Tools/Reference or Business Practice Documents

1. Training and projects

• Guide and advice on GDP and GMP matters.
• Participate in the training of newcomers
• Collaborate to projects as subject matter expert for logistics, qualification or other type of activities where relevant.

1. External relations/others

• Act as the QA contact person between ELECTS and the External Parties for Qualification.
• Act as a contact for the Global Quality Audit and Compliance Group (GQAAC).
• Interact with the clinical teams

1. Health, Safety and Environment

• Carry out the activities in accordance with company and site safety and environmental requirements.

1. Confidentiality

• Ensure that confidential information remains confidential.

1. Quality Culture

• Make quality culture the foundation of your work, to ensure our products are safe and effective to improve patients’ lives.
• Maintain ownership and emphasis on quality, ensuring quality in all daily activities.
• Demonstrate engagement and employ a quality mindset in all endeavors by proactively identifying quality issues and communicate appropriately.