At Lilly, the business and technical problem is to support the development and implementation of strategy for quality systems and activities to support business goals and objectives, ensuring compliance, quality oversight, audit/inspection support, and collaboration within quality and other areas.
Requirements
- Demonstrated ability to apply quality systems within a regulated work environment
- Knowledge of quality systems
- Serve as an IT systems business quality assurance (BQA) representative for IT systems, as assigned.
- Perform all responsibilities of IT Business Quality as defined in Computer System Policies and Procedures.
- Review and approve as appropriate, documents associated with the development and maintenance of IT systems as the representative of MQO, Regulatory Quality.
- Partner with IT and the business on system related initiatives/changes as the BQA for assigned IT systems.
- 2+ years experience in a quality control/quality assurance role supporting Pharmacovigilance (PV)
Responsibilities
- Contribute to the development of area specific procedures and required tools, resource documents and supplemental materials, including review and content approval (as assigned) of quality system documents.
- Recommends new quality system documents or changes to existing quality system documents where applicable.
- Responsible for deviations, change controls, Notification to Management (NTM), ensuring events are appropriately documented, escalated, and completed.
- Consult on root cause analysis and corrective/preventive actions (CAPA) including review/approval as necessary.
- Provides input into risk assessments, audit planning and/or quality plans based on identified signal/risks/gaps.
- Complete self-inspections and drive improvements that are meaningful and actionable.
- Provides support related to external party management (for example, third-party organizations, business alliance partners) as assigned.
Other
- Bachelor’s Degree required
- Effective project and time management skills
- Demonstrated ability to communicate effectively, both written and verbal, and to influence others
- Demonstrated ability to prioritize and handle multiple concurrent tasks
- Candidates must reside near Indianapolis, IN or be willing to relocate
