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 patients around the world.
Eli Lilly Cork is made up of a talented diverse team of over 1,800 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.
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.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!
Organization Overview: The Medical Quality Organization (MQO) is actively seeking a Research and Clinical Laboratory Quality Representative. This individual will be tasked with upholding data integrity and compliance across a diverse array of laboratory environments, including discovery research, clinical laboratories, and clinical trials. The role involves ensuring adherence to quality systems, driving improvements, and fostering cross-functional collaboration with a variety of business partners.
Furthermore, the MQO Research and Clinical Laboratory Quality Representative supports the portfolio and clinical diagnostic laboratory deliverables. This will involve harnessing Data-Driven Quality initiatives, cultivating deeper quality and technical expertise, and integrating quality into innovation. MQO seeks individuals with high learning agility and adaptability to support and manage the ever-evolving regulatory landscape. This position offers a unique opportunity to lead, learn, and make a significant impact in the field of medical quality assurance.
Responsibilities: Understands Quality Systems (SEQS and DRQS): Procedures, Tools, Resources and how these are applied to business processes.Understands quality principles.Monitors and manages compliance, compliance issues, and understands appropriate escalation as necessary.Manages and implements business work via the Quality Management System: Notification to Management, Deviations, Root Cause Analysis, Change Control, etc.Solves problems related to quality issues using good judgement-based decision-making principles.Manages business focused expectations.Establishes experiences working within a global capacity.Ensures compliance with Quality Systems, internal guidelines, and external regulations.Consults with business partners for strategic and practical application of policies and procedures.Demonstrates ability to negotiate, influence, and problem-solving behaviors.Demonstrates inclusive, team-focused behavior.Demonstrates good verbal and written communication in English.Demonstrates good project management, prioritization, and evaluation of critical from non-critical issues.Demonstrates ability to identify root causes, manage difficult business/quality issues.Enables execution of local, regional, and global regulatory requirements for laboratory and diagnostic.Influences direction of quality decisions, partners with cross-functional teams and provides technical and regulatory considerations.Implements the Quality Plans as appropriate for the relevant systems.Consults and facilitates audits and management of associated audit observations for the business and related TPOs.Evaluates business metrics for trends, identifies gaps, areas of weakness.Drives simplification, shares key learnings, seeks process improvements, and replicates best practices; Partners with business process owners; Utilizes risk-based approaches.Reviews, edits, manages and approves business documents.Handles sensitive information with confidentiality.Provides periodic Quality updates with business leadership.Supports projects as needed.Consults with other functional representatives, as necessary.Manages the recruitment, development, retention of a highly capable and diverse team.Ensures assignment of relevant training, completion of work expectations, MQO competencies and assignment of coaches as needed.Understands core functional business processes.Understands in depth Laboratory systems, Laboratory Data requirements, Data integrity.Understands working with Third Party Organizations related to services including but not limited to: Clinical Laboratory and Diagnostics, such as imaging, ECGs and connected device requirements.Manages global regulatory inspection activities, including continuous inspection readiness and management of regulatory responses/ Corrective Actions/ Preventative actions.Utilizes and manages quality metrics for process improvement initiatives.Exhibits expertise in LIS management, validation, archiving, audit train expectations, and regulatory requirements.Demonstrates experience in CLIA, GLP, or other Research related laboratories.Understands Clinical and non-clinical Drug Development and GxP regulations, guidelines, and standards.Understands Third-Party Management, TPO On-boarding, Oversight and Quality expectations.Consults Information Technology and associate IT Quality representatives as necessary.Consults and supports implementation of new processes, advises on training requirements and quality content for business processes.Consults in assessment of risk, audit planning and quality plans.Ensures appropriate controls are implemented and documented for business or regulatory requirements. Basic Requirements: Bachelor's degree in Clinical Laboratory Sciences/ Medical Technology, life sciences, medically related field or equivalent work experience.Minimum 2-3 years of experience in a Clinical Laboratory, Pharmaceutical Research and/or Quality.Additional Skills/Preferences: Direct experience within Quality and/or demonstrated understanding and application of quality management systems.Advanced degree in a scientific field, statistics, or data science.Supervisory experience.Experience working in a global environment.Proven mastery of data integrity principles in drug development and clinical research.Demonstrated competency in engaging cross-functional team members to resolve issues while balancing timelines, various perspectives, and speaking up/leading when the destination is unclear.Strong leadership and self-management skills.Strong verbal and written communication skills.Knowledge of CLIA, GCP guidelines, GxPs, and regulations within the area of responsibility.Demonstrated problem solving and critical thinking skills.
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