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.
At Eli Lilly Cork, we unite caring with discovery to make life better for people around the world.
Our 45,000 employees 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.
Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions across various Business Service functions including Finance, Information Technology, Medical, Clinical Trials, and more.
Eli Lilly Cork offers a premium workspace with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies, and on-site parking.
In-house People Development services, Educational Assistance, and our 'Live Your BEST Life' wellbeing initiatives enhance the career experience for our colleagues.
Eli Lilly Cork is committed to diversity, equity, and inclusion (DEI), ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities, and gender, with four pillars: EnAble, embRACE, LGBTQ+ & Ally, and GIN-Gender Inclusion Network.
EnAble partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all.
The Clinical Drug Supply organization team is responsible for providing Investigational Product (study drug) management services for global clinical trials in all development phases, including partnering with medical teams to develop compound and study supply plans, package design, label creation, and other deliverables to support clinical trials.
The team also provides oversight of business processes related to on-time study drug delivery at clinical trial sites.
The Clinical Drug Supply Compliance Associate/Senior Associate/Manager will interact and communicate with the Clinical Drug Supply teams, leveraging project management skills to manage CAPA (Corrective and Preventive Actions) changes and events, change controls, deviations, and other compliance-related activities within the TrackWise system.
They will aid Clinical Drug Supply teams to ensure that processes and quality systems are well managed and evaluate and provide corrective and preventative actions when breakdowns occur.
The role is responsible for providing TrackWise support for the team, including assistance with investigations and root cause analysis, and proactive communications on upcoming CAPA deliverables.
Key Responsibilities Make quality culture the foundation of your work, ensuring our products are safe and effective to improve patients' lives. Proactively track and monitor all TrackWise and related compliance commitment activities/due dates for the Clinical Drug Supply organization. Create and enter observation records/CAPA events and change controls into TrackWise, monitoring and tracking progress throughout the lifecycle. Maintain open lines of communication with management, customers, and vendors to relay critical issues and improve turnaround times for CAPA, deviations, and changes. Work with Clinical Drug Supply team members, including quality, to assist/support completion of deviations and changes that support improvements to current processes. Leverage project management skills to develop plans for change controls and events, ensuring proactive communications and on-time completion. Develop and maintain CAPA expertise and TrackWise knowledge. Lead and assist in identifying root causes when issues occur and develop, recommend, communicate, and implement corrective actions and lessons learned. Work across multiple functional areas with individuals of all levels of the organization. Collect and report metrics and completion of other quality needs/activities as requested from supervisor or Quality department. Minimum Requirements Bachelor's degree, + 2 years of TrackWise experience/experience in Quality or Clinical/Supply related field. Must speak fluent English. Additional Requirements: Strong attention to detail and quality focus. Ability to proactively work with the business to foster a quality culture. Ability to collaborate cross-functionally with people of all levels of the organization. Strong oral and written communication skills. Strong working knowledge of Excel, Word, PowerPoint, TrackWise, and QualityDocs program. Previous root cause analysis experience. Additional Information/Requirements: Work outside of core hours may be required to support the portfolio across the globe. Minimal travel may be required, both domestic and international. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions.
If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance.
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.
#WeAreLilly
#J-18808-Ljbffr