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Lilly Sr Principal Associate- Research and Clinical Lab Quality Medicines Quality Organization (MQO) Corporate in Indianapolis, Indiana

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 35,000 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 people around the world.

Organization Overview

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

The purpose of the Sr Principal Associate-Research and Clinical Lab Quality, MQO Corporate role is to be the quality expert for the areas of Research Discovery Labs and Clinical Laboratory Services (regional/affiliate, portfolio and/or functional business units). The Consultant actively participates in strategic planning to strengthen the quality of Medical Research, Safety and Efficacy Quality System (SEQS) and, Discovery Research Quality System (DRQS) effectiveness and the integration of quality into business processes. The Consultant is responsible for the implementation of quality initiatives and providing guidance to teams. This role will lead and drive implementation of the SEQS and DRQS Research and Clinical Lab process improvements.

Responsibilities :

Functional and Technical Expertise

  • Familiar with regulations and guidelines: provides interpretation, direct input into quality systems and defines the quality direction to comply with external and internal expectations

  • Provides guidance and expectations to the business to enable execution of regulationson a local, regional and global level ensuring compliance and inspection readiness

  • Provides key input into the design ofSEQS/DRQS and leads implementation into the business areas

Participates in SEQS/DRQS procedure development and in Change Control as appropriate

  • Provides input and feedback on quality standards and expectations.Is accountable for the implementation and delivery of milestones for the quality system

  • Accountable for the development and implementation of the quality strategy for the portfolio and functions, partners with business to complete quality risk assessments and developa risk management plans

  • Performs on-going risk assessment and evaluation of the quality of medical research to identify performance/compliance gaps relative to current regulations and company standards, guidelines and internal procedures and recommends robust corrective actions

  • Expert in corrective and preventative actions (CAPA) management. Supports/educates the business in developing robust CAPA and monitors through to resolution.

  • Expert in Deviation Management/Root Cause Investigation

  • Expert in audit and inspection response management

  • Reports issues through Notification to Management (NTM) as appropriate

  • Evaluates and approves change management proposals to ensure changes are appropriately assessed, documented and valid. Provides input into Global Quality Auditing and Compliance (GQAAC) audit plans a based on identified signal/risks/gaps

  • Defines, executes and documents quality self-assessments checks/self-inspections throughout the clinical development process and discusses output with business partners

  • Supports Business Quality Assurance for critical business systems in area of responsibility (i.e. LEO, IMPACT)

Inspection Readiness and Inspection Management

  • Leads pre-inspection preparation activities in collaboration with business partners

  • Prepares and educates internal and external customers/business partners (including investigator site staff) on inspection management

  • Actively supports site and sponsor inspections

  • Responsible for inspection response management and tracking through resolution

  • Coordinates audit responses including Trackwise system documentation

  • Functions as an expert in corrective and preventative actions (CAPA) management

  • Actively participates in lessons learned/shared learning sessions regarding clinical trial site support during inspections

Quality Decision Making

  • Responsible for quality consultation across clinical research development (protocol to disclosure) involving interactions with all levels across the organizations, including groups such as Legal, Compliance, Finance, Medicines Development Unit (MDU) etc.

  • Consults on root cause analysis with internal and external business customers/partners to identify solutions and prevent issues that impact function or geography

Influence Quality Direction

  • Leads the direction of quality for supported area/function and works with other consultants to ensure consistent practices are employed

  • Provides technical and team leadership for quality, portfolio, medical affairs, and divisional projects. Ability to engage and influence leadership across organizations (Legal, Compliance, Finance, MDU, External Partners/Customers etc.) to resolve complex issues

  • Leads the team to deliver innovative solutions, preventing re-occurrence of issues

  • Utilizes quality experience to support change management and business transformation in the delivery of the portfolio

Problem Solving

  • Leads teams in the process of resolution of issues; including resolution of conflict and building an environment to focus on the resolution of issues. Escalates issues and manages the interfaces to ensure issues are resolved

  • Raises issues to management, including issues that could have the ability to impact the portfolio. Develops well thought out solutions and presents clear action plans

Quality Technical Leadership

  • Provides key data (compliance, conformance, risks, issues) to senior management to drive decision making in support of the portfolio

  • Initiates, drives and coordinates quality improvement initiatives across affiliate, site(s) or functions

  • Key resource in the development of new business process and partnerships - developing quality agreements and directing management of key steps required to ensure quality, including evaluating (risk assessment or vendor assessment) the partnership (third party or alliance), the program and setting forth the quality direction and approving oversight plans

  • Leads the harmonization of best practices and projects across the regions, functions and other Quality organizations and recommends key projects

Project Management

  • Engages and mobilizes cross functional and geographical work teams to deliver projects successfully - influences assignment of resources to enable project progress

  • Utilizes project planning and maximizes the use of the SixSigma methodology to achieve project results. Builds innovative, simple and workable solutions to solve business problems

Customer/External Focus

  • Sets the quality expectation for third party partners and advises on requirements and inspection needs

  • Acts as quality expert consultant to the business and external parties. Builds relationships with internal and external customers and partners

  • Leads the development of quality agreements internally and with external parties and alliances. Interacts with regulators, customers or other outside stakeholders on business issues

  • Manages audits and regulatory inspections in cross-functional company areas, across regions and with external partners

Basic Requirements:

  • Bachelor's Degree in a science, technology or medically related field or equivalent relevant work experience

  • At least 3 years of experience in pharmaceutical research and/or quality

Additional Preferences:

  • Global perspective and working across functional and geographical boundaries

  • Extensive knowledge of GxP regulations, guidelines, and standards

  • Demonstrated understanding of quality management system principles, including policies, procedures, and processes

  • Demonstrated ability to identify root cause and manage difficult global business/quality issues. Ability to separate critical from non-critical issues

  • Knowledge of the international regulatory framework

  • Ability to influence, negotiate and project manage

  • Ability to work effectively at all levels of the organization

  • Excellent problem solving skills and initiative

  • Proficient written and spoken English language skills

  • Effective verbal communication

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.

Lilly is an EEO/Affirmative Action Employer and 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.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).