Lilly Consultant – QA Clinical Services, Supplies & Capabilities in Indianapolis, Indiana
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 35,000 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.
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Main Purpose and Objectives of Position:
The Clinical Services, Supplies & Capabilities (CSSC) organization is responsible for strategically planning and supplying materials, trial support services and innovative capabilities to support the execution of clinical trials globally for all business units across all phases of development. This group is within the Clinical Capabilities organization and partners across functions within the CDDA and PRD to influence trial design and provide solutions to operationalize these trials and enable asset strategies across the portfolio.
The Consultant – QA Clinical Services, Supplies & Capabilities within Development-Quality Assurance provides quality oversight, guidance, and support for the development and implementation of new and emerging capabilities in support of the CSSC organization. These include providing cGMP/cGDP/cGXP interpretation and guidance for the continued development and expanded use of capabilities in support of internal and externally sponsored trials. These capabilities may include continued development of new models for providing drug products, ancillary supplies, devices (direct to patient/site to patient), expanded use of central pharmacies and other decentralized capabilities. The consultant will partner to develop vendor oversight strategies, operational procedures, policies, and guidance in support of and compliance to procedures, policies, and guidelines.
Provide oversight, guidance, and support for the development and implementation of operational models to provide clinical supplies and related services to our internal and external portfolio. These included but are not limited to sourcing strategies, commercial products, ancillaries, mobile health care models, direct to patient, new site modalities and decentralized capabilities within Lilly Product Research and Development (PR&D).
Support and provide quality oversight of improvement projects in the CSSC space, especially as it applies to new capabilities and related services.
Develop, monitor, and trend quality indicators/metrics in support of CSSC initiatives to identify opportunities for improvement.
Provide quality oversight and maintain the qualified status of external partners and new capabilities across the space.
Provide qualification and oversight of novel distribution activities ensuring that appropriate processes are put in place to support new activities.
Ensure appropriate execution of the respective Quality Systems to ensure cGMPs/cGDP compliance.
Identify, communicate, and lead resolution efforts for systemic Quality System gaps;
Develop SOPs based on required quality principles and cGMPs/cGDPs.
Participate and present Quality status and updates at Quarterly Business Review and Steering Committee meetings.
Network, both internally and externally, to understand best practices, share knowledge, participate in tactical and strategic business planning, and to ensure all Quality requirements are met or exceeded.
Interact with regulatory agencies during inspections.
Lead and participate in internal site self-inspections.
Review, approve, and trend deviation investigations.
As needed, actively participate on the PR&D Quality Lead Team.
Other duties as assigned.
Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, Engineering or Business
License/Certificate Requirements: Not Applicable
Language Requirements: Not Applicable
General understanding of how different health care settings operate.
Experience with healthcare/pharmaceutical distribution operations.
Clear understanding of cGCPs, cGMPs and cGDPs, policies, procedures, and guidelines related to distribution of clinical trial materials.
Strong communication skills, both written and verbal, and ability to manage external partners.
High-quality skills including: ability to prioritize, critical decision making, interpersonal/people, problem solving.
Strong understanding of Quality systems and knowledge/experience in Trackwise, SAP, CTWIN, and Quality Docs.
Experience understanding, following, and interpreting state pharmacy laws.
Pharmacist, Nurse, or related health care professional preferred.
Previous quality assurance experience.
Lilly is an EEO/Affirmative Action Employer and 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.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company. If you would like to request an accommodation for medical or religious reasons, you may do so at firstname.lastname@example.org.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!