Eli Lilly
Job title:
Associate / Sr. Associate – Clinical Drug Supply Compliance
Company
Eli Lilly
Job description
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. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our
45,000 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 patients around the world.
Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60
nationalities who deliver innovative solutions that add value across a variety of Business
Service functions including Finance, Information Technology, Medical, Clinical Trials
and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island,
complete with flexible hybrid working options, healthcare, pension and life assurance
benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse
People Development services, Educational Assistance, and our ‘Live Your BEST Life’
wellbeing initiatives are just some of the holistic benefits that enhance the career
experience for our colleagues.
Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all
dimensions 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, our pillar
for people with disabilities and those that care for them, partners with the Access Lilly
initiative to make our physical and digital environment accessible and inclusive for all.
Together they are committed to promoting awareness to create a disability confident
culture both at Eli Lilly Cork and beyond.
Come join our team – Be Creative, Be an Innovator, and most of all, Be Yourself!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 withmedical teams to develop compound and study supply plans, package design, label creation and otherdeliverables to support clinical trials. The Clinical Drug Supply organization 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, leverage 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. In addition, they will aid Clinical Drug Supply teams to help ensure that our processes and quality systems are well managed and when breakdowns occur, we aggressively evaluate and provide corrective and preventative actions. The Clinical Drug Supply Compliance Associate/Senior Associate/Manager is responsible for providing TrackWise support for the Clinical Drug Supply team, including assistance with investigations and root cause analysis and proactive communications on upcoming CAPA deliverables. The Clinical Drug Supply Compliance Associate/Senior Associate/Manager helps to ensure that the Clinical Drug Supply function maintains the highest quality standards and complies with regulations and quality system requirements.Key Responsibilities
- Make quality culture the foundation of your work, to ensure 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. Provide communication and follow up throughout the organization to help ensure on-time completion.
- Create and enter observation records/ CAPA events and change controls into TrackWise, monitor and track progress throughout the lifecycle.
- Maintain open lines of communication with management, customers, and vendors to relay critical issues and improve turn-around 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 pro-active communications and on-time completion of events and changes.
- 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 & completion of other quality needs/activities as requested from supervisor or Quality department.
Minimum Requirements
- Bachelor’s degree, + 2yrs of TrackWise experience / experience in Quality or Clinical/Supply related field.
Language Requirements: 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 ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.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
Expected salary
Location
Cork
Job date
Tue, 07 Jan 2025 23:57:49 GMT
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