Associate / Sr. Associate - Medicines Quality Organization

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 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 39,000 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 1,400 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.

Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!

Purpose

The purpose of the Associate/Senior Associate – MQO is to support the development and implementation of the strategy for quality systems and activities to support business goals and objectives. This includes execution of quality system deliverables to ensure compliance, quality oversight of business areas to integrate requirements, audit/inspection support and collaboration within quality and other areas. Pharmacovigilance experience is essential to a successful candidate as they will be directly supporting the Safety Management group in Cork.

Primary Responsibilities

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

Implement and Manage Quality Systems

• 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.  Ensures the regional and/or affiliate quality system requirements have clear accountabilities, as assigned. 

• Recommends new quality system documents or changes to existing quality system documents where applicable.

• Advise on appropriate training for implementation and documentation.

• Provide consultation on the interpretation and practical application of external requirements, standards, and procedures.

• 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

• Ensure local implementation of the quality systems as necessary. 

• Provides support related to external party management (for example, third-party organizations, business alliance partners) as assigned.

Provide Quality Oversight for business area(s)

• Monitor for compliance to quality system documents.  Anticipates gaps and proactively proposes solutions.

• Communicates and escalates to management as appropriate.

• Ensure implementation of regional and/or affiliate Quality Plan(s) as necessary. Monitor progress of actions.

• Provide updates to quality and business owners