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.
Cork Site Overview
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.
Why Work at Lilly?
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.
Purpose and Responsibilities
The purpose of the Associate / Sr Associate MQO - Trial Capabilities role 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.
* Implement and Manage Quality Systems
o Contribute to the development and review of country/region specific quality system documents to ensure requirements and accountabilities are represented.
o Approve regional and/or local required tools, resources, forms, templates.
o Assist in interpreting relevant regulations and guidelines and act as a contact person for global and affiliates.
o Recommend new procedures or changes to existing procedures where applicable.
* Provide Quality Oversight for business area(s)
o Monitors and provide quality oversight for compliance to Safety & Efficacy Quality System (SEQS).
o Communicates and escalates compliance issues to management locally and globally, as appropriate.
o Provide consultation on the interpretation and practical application of external requirements, standards, and procedures.
o Ensure implementation of regional and/or affiliate Quality Plan(s) as necessary. Monitor progress of actions and provide updates to business and quality leadership.
* Audits and Inspections
o Facilitate audits/inspections (for example, preparation/readiness, coordination, back room, front room, responses).
o Manage audit and/or inspection responses.
o Communicate and ensure inspection readiness requirements are in place, being organisation and availability of documents such as training records, job description, backroom and/or front room organization.
* Partnership with other area(s)
o Functions as the initial point of consultation for business areas on quality related questions.
o Partners with the business area(s) to strengthen and ensure appropriate quality controls are in place.
o Shares key learning to drive simplification and replicate best practices.
Minimum Qualification Requirements
1. Bachelor's or Master's degree in a science or health care related field, Health care professional, such as: Pharmacist, Nurse.
2. Three years experience in quality and/or drug product safety/regulatory.
3. Demonstrated ability to implement, interpret and apply quality systems within a regulated work environment (such as GMP, GCP, GVP).
4. Cognitive abilities which include problem solving, verbal reasoning, attention to detail, critical thinking and analytical competencies.
5. Demonstrated ability to communicate effectively, both written and verbal, and to influence others.
6. Demonstrated ability to prioritise and handle multiple concurrent tasks.
7. Demonstrated ability to apply risk-based decision making in a regulated environment.
Other Information/Additional Preferences
1. Demonstrated ability to work in a global environment.
2. Cultural sensitivity.
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.