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 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, Age & Culture, LGBTQ+ 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!

Purpose

The Sr. Associate, GMQO Audit & Inspection Management provides essential support, oversight, and education to quality and business personnel concerning various components of the quality system, with a primary focus on Audits and Inspections and Notification to Management (NTM). This role plays a critical role in ensuring GMQO’s readiness for audits and inspections, enhancing quality system components, and supporting continuous improvement efforts with the GMQO Process Owner for Audits and Inspections. The Sr. Associate reports directly to the Associate Director, GMQO Compliance and Quality Analytics.

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.

1. General Responsibilities

Provides support, monitoring, and education to quality and business personnel for assigned quality system components, including, but not limited to Audits and Inspections, Notification to Management (NTM).

Works closely with the GMQO process owner for Audits and Inspections for the monitoring and continuous improvement of the process.

Serves as SharePoint Site Administrator (MIM sites) in the development and management of a cross functional inspection management infrastructure for logistics, preparation/planning, and close out activities including tracking all sponsor requests and facilitating inspection management response process.

Administratively and logistically facilitates and manages backroom for sponsor inspections and audits hosted by Medicines Quality Organization.

Manages the appropriate archiving of audits and inspections data and retrieval of documentation from various systems to support audits and inspections including master SOP list and documents in long-term storage or eArchive.

Performs timely data entry as relates to audit / inspection conduct into Trackwise/OneQMS and maintain, analyze, and facilitate any actions as a result of bi-monthly inspection update metrics used by management and GMQO for inspection readiness.

Coordinates routine and ad-hoc mock inspections / rehearsals

Maintains inspection readiness artifacts including but not limited to: Inspection Distribution List; Inspection Presentations; Inspection Organization Chart; Audit and Inspection Training.

Participates in industry forums for inspection readiness information exchange and benchmarking as applicable.

Lead, or conduct other projects /tasks as requested in the management of audit and inspection activities.

2. Metrics and Data

Responsible for compiling and reporting of audit / inspection compliance metrics at appropriate levels for management review.

Performs trend analysis on inspection and audit issues/observations to provide meaningful and actionable data at governance meetings and for use in ongoing inspection readiness.

Participates in the preparation of annual audit and self-inspection plans in collaboration with management and GQAAC.

Participates in Management Review preparations for audit and inspection data in collaboration with Standard owners and GQAAC.

Minimum Qualification Requirements

Bachelor’s degree

Experience in Inspection/Audit preparation of Sponsor and related sites (eg clinical sites) within a GCP/GLP/GPvP environment).

Experience with IT/systems supporting quality; specifically, TrackWise, OneQMS, Notification to Management, SharePoint and Power BI a plus.

Knowledge of GLP, GCP and GVP global regulations as they relate to Clinical Development, Drug Safety and Drug Development.

Excellent communication skills, both written and oral. Ability to effectively develop and present information to all levels of the organization.

Prioritize and handle multiple concurrent tasks and good planning and organization skills.

Work across functions to obtain input, resolve differences, and achieve results.

Effectively apply judgment-based decision making in a regulated environment

Other Information/Additional Preferences

5 years of experience in the Pharmaceutical Industry

Demonstrated ability to assess the state of current business and operations to identify and recommend future state, improvements, and implement action plans.

Understanding of being risk based focused and prioritizing work based on Risk Management methodologies.

Work in a team matrix environment and independently interact with various levels of management.

Limited travel: 0-10%

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. 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.

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