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.
Eli Lilly Cork, is made up of a talented diverse team of over 1,600 employees across 38 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more.
Lilly 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.
Our purpose at Eli Lilly Cork is to support the development and implementation of quality systems strategy and activities to support International Business Unit (IBU) goals and objectives for assigned countries or regions. This role will implement the quality plan and ensure consistency between the global requirements and local requirements, focusing on Safety and Efficacy quality system and ensuring this system is aligned with appropriate quality and regulatory requirements. Provide updates on internal/external GxP trends and changes through the country/regional affiliate leadership team(s). Acting as a contact person regarding quality and business process compliance concerns between affiliates and global.
We are seeking an Associate / Sr Associate MQO - Trial Capabilities to support the business on the application and facilitation of quality systems, deviations, notification to management, change control. The successful candidate will be responsible for implementing and managing quality systems, providing quality oversight for business area(s), conducting audits and inspections, and partnering with other area(s).
This role requires a Bachelor's or Master's degree in a science or health care related field, Health care professional, such as: Pharmacist, Nurse, with three years experience in quality and/or drug product safety/regulatory. Demonstrated ability to implement, interpret and apply quality systems within a regulated work environment (such as GMP, GCP, GVP). Cognitive abilities which include problem solving, verbal reasoning, attention to detail, critical thinking and analytical competencies, demonstrated ability to communicate effectively, both written and verbal, and to influence others, demonstrated ability to prioritise and handle multiple concurrent tasks, demonstrated ability to apply risk-based decision making in a regulated environment.