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.About UsAt 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 2,000 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 YourselfJob DescriptionRoles and Responsibilities include Recognize, exemplify and adhere to the Lilly values which center on our commitment to People, Excellence and Compliance.This role reports to the Quality Assurance Associate Director for GBS Cork, Kuala Lumpur and Mexico. In collaboration with Affiliates, Order to Cash Operations, Regional Quality and GBS QA Lead you will support the implementation, maintenance and operations of the Quality systems for the Global Business Solutions center.For the Global Business Solutions Center you will support and manage GMP compliance and GDP (Good Distribution Practice) activities and GMP decisions on Products and Quality issues in conjunction with the appropriate Affiliate Product Quality Representative, Regional Quality Leader and GBS QA Associate Director.The Key Elements Of The Role Will IncludeQuality System ActivitiesResponsible to support the SOP system ie. from initiation to review and approvalResponsible to support the GMP record retention systemSupport the product quality Personnel Qualification activitiesSupport the Deviation & Change Control system (inclusive of evaluations, close out, tracking and trending)Manage and support the Quality Plan (action owner and final close out)Support the Quality ManualSupport Recall activities ie. local at GBS and AffiliateSupport Product Complaints managementSupport projects with Quality involvement and may lead small to medium projects or programs with minimal to moderate risks and resource/financial requirementsProduct Quality instructor /trainer for personnel (GMP Induction and GMP refresher)Responsible for the Quality Management activities within our ERP system (SAP) associated to Customers and Material MasterCompliance ActivitiesSupport compliance with any applicable Global Quality Standard & with the Quality Agreement in place between Global Business Solutions Cork & Affiliates ( including maintaining updates)Makes decisions within guidelines and policies where appropriate ie. provide support for quality compliance in accordance with the Global Quality Lilly Standards and Health Authority requirementsSupport Audits and Self assessments preparation and observations completion ( internally at GBS and Affiliate where necessary)Ensure that the regulatory and Quality impact review is done for deviations and Change ControlBusiness SupportSupport the GMP compliance of the SAP activities performed by the Global Business Solutions CenterEnsure the Global Business Solutions Center is following the appropriate Quality systems & specific requirements from Affiliates as part of the routine operationsEnsure Quality coverage to the Supply Chain activities & interactions between Lilly Service Providers & AffiliatesSupport and Manage the Quality oversight of the Inventory Management systems ie. Expiration & retest monitoring, returns, destruction and adjustment of inventories.Help, give guidance and problem solve on resolution of complex Quality issuesAnticipates customer needs and handles non-standard requestsQuality Activities within IT solution for GBSSupport the Quality Management activities within SAP – QM Power users & QM Data Steward activitiesSupport and manage order overrides within SAP where applicableSupport and manage DSP requestsCommunication ActivitiesA Quality Contact and active communicator within the Global Business Solutions CenterActive communication with the affiliate/QA colleaguesHas impact within related departments or areasGMP InstructorCommunication with Affiliate QA and Regulatory for product destination countryCreate, Promote and Maintain Operational ExcellenceActively work in partnership with various cross-functional stakeholders (internally & externally) to maintain effective relationships and ensuring efficient and compliant processesEnsure the culture of compliance is reinforced continuously within the teamContinuously look for and or lead where possible continuous improvement initiatives including standardization and/or re-engineering of processes and controlsDrive for results and ensure best practices are in place to achieve highest standards within daily operationsDrive cross-functional projects where opportunity arisesDemonstrate excellent project management abilities and strong understanding of financial systemsSupport organizational changesAnalyse and translate data into key strategic inputs and insights to drive decision makingProven ability to work on high level value-add ad hoc projects while continuing to achieve routine goalsPersonal AttributesAbility to handle complexity and utilize analytical skills, with attention to detail and a risk based solution oriented approachAbility to effectively prioritize and complete key tasks and deliverables whilst also engaging others to achieve their deadlines towards compliance and change initiativesAbility to communicate effectively and influence across all levels and disciplines of the organisationAbility to be flexibleAppreciation of cultural diversityEducationDegree in scientific disciplines such as Pharmacy, Chemistry, Biochemistry, Microbiology or other relevant Pharma experience positions.Previous Experience3 to 5 years experience within Quality Assurance, Supplier Quality, Regulatory, Medical Information, Laboratory, Supply Chain, Master Data or Quality related roles within Pharma.Language RequirementEnglishIT LiteracyProficient in MS OfficeGood working knowledge in SAP is an advantageTrackwiseLilly 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.WeAreLillyUKandIreland