At Lilly, the business problem is to ensure quality support for the Greenwoon Innovation Center (GIC) and to drive large-scale quality improvement projects, influencing direction for GIC, while providing 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.
Requirements
- 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
- Experience working in distribution, packaging, and/or with cold chain processes
- Proven ability to influence globally diverse groups and to effectively manage relationships
Responsibilities
- 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.
- 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.
Other
- 3 days onsite required at our Greenwood Innovation Center in Greenwood, IN
- 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
- Ability to work with people with disabilities and provide accommodation as needed
- Must be eligible to work in the United States
