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.
The Manager - QA will be responsible for quality support for the Greenwoon Innovation Center (GIC).
The QA Associate will drive large-scale quality improvement projects and influence direction for GIC. The Associate and Advisor - QA PR&D Centralized Services and Supplies provide quality oversight, guidance, and support for the development and implementation of new and emerging capabilities in support of the PR&D Clinical Central Services 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), convenience kitting, expanded use of central pharmacies and other decentralized capabilities. The Associate and Advisor will partner to develop vendor oversight strategies, operational procedures, policies, and guidance in support of and compliance to procedures, policies, and guidelines. The employee will have direct Quality oversight for the Greenwood Innovation Center (GIC).
Specific responsibilities include:
- Practical application of ICHQ9 (Quality Risk Management) and ICHQ10 (Quality Systems) to GIC operations, using Lilly quality standards
- 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 include, but are not limited to, sourcing strategies, mobile health care models, convenience kitting, direct to patient initiatives, new site modalities and decentralized capabilities within Lilly Product Research and Development (PR&D).
- Provide appropriate level of oversight for receipt, storage, and distribution of items in the GIC including ancillaries, associated supplies, clinically managed supplies, and operational supplies.
- Serve as the BQA (Business Quality Associate) in support of computer systems associated with the GIC.
- Support and provide quality oversight for Direct-to-Patient and other Decentralized Clinical Trial models.
- Support and provide quality oversight of improvement projects in the PR&D Clinical Central Services space, especially as it applies to new capabilities and related services.
- Develop, monitor, and trend quality indicators/metrics in support of PR&D Clinical Central Services initiatives to identify opportunities for improvement.
- Network, both internally and externally, to understand best practices, share knowledge and to ensure all Quality requirements are met.
- Support the Operations organization by
- Timely and accurate reporting, change controls, action item completion, and investigations
- Collaborate with other functions, including hands-on work experience and shared learning
- Benchmarking with other Lilly sites to gain support for solutions
Basic Qualifications
- Bachelor's degree in Pharmacy, Chemistry or related science degree, or equivalent experience
- 5+ years working in pharmaceutical manufacturing and/or experience working with Medical Quality and/or Clinical Trials distribution process
- Understanding/experience with ICH Q9 and/or Lilly's Quality Risk Management standards
Additional Skills/ Preferences
- Experience working in distribution, packaging, and/or with cold chain processes
- Proven ability to influence globally diverse groups and to effectively manage relationships
This role is located at our Greenwood Innovation Center in Greenwood, IN and is not approved for remote work. 3 days onsite required.
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Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$63,000 - $162,800
Full-time equivalent employees also will 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 company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); 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.