Join American pharmaceutical leader Eli Lilly and Company, currently hiring Sr Principal Associate, Medicines Quality Organization (MQO) Corporate in Indianapolis, Apply Lilly careers in Indianapolis Indiana.
Position : Sr Principal Associate, Medicines Quality Organization (MQO) Corporate
Location : Indianapolis, Indiana
Job id: R-32976
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.Purpose:The purpose of the MQO Corporate role is to be the quality expert for their given area of responsibility (Statistics, Data and Analytics). The MQO actively participates in strategic planning to strengthen the quality of Medical Research, Safety and Efficacy Quality System (SEQS) effectiveness, and the integration of quality into business processes. The MQO is also responsible for the implementation of quality initiatives and providing guidance to teams using judgement-based decision making and focusing on data integrity.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 supervision regarding your actual job responsibilities and any related duties that may be required for the position.Functional and Technical ExpertiseFamiliar 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 regulations on a local, regional and global level ensuring compliance and inspection readiness.Provides key input into the design of SEQS and leads implementation into the business area.Participates in SEQS 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 develop a 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 based on identified signals/risks/gaps.Defines, executes and documents quality self assessment 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.Inspection Readiness and Inspection ManagementLeads 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 MakingResponsible 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, Clinical Development, 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 DirectionLeads 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, CDDA, 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 delivery of the portfolio.Problem SolvingLeads 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 LeadershipProvides key data (compliance, conformance, risks, issues, etc.) 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) 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 ManagementEngages 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 agile, risk-based sprint methodology to achieve project results. Builds innovative, simple and workable solutions to solve business problems.Customer/External FocusSets 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 Qualification/Requirements: Bachelors Degree in statistics, a science or data science, technology or medically-related field or equivalent relevant work experienceAt least 3+ years of relevant industry experience, preferably in pharmaceutical/medical research and/or qualityAdditional Preferences:Global perspective and working across functional and geographical boundariesExtensive knowledge of GxP regulations, guidelines and standardsDemonstrated understanding of quality management system principles, including policies, procedures and processesDemonstrated ability to identify root cause, manage difficult global business/quality issues, and separate critical from non-critical issuesKnowledge of the international regulatory frameworkAbility to influence, negotiate and project manageAbility to work effectively at all levels of the organizationExcellent problem solving skills and initiativeProficient written and spoken English language skillsEffective verbal communicationDemonstrated inclusive, team-focused behaviorsEli 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 ( Lilly_Recruiting_Compliance@lists.lilly.com ) 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).
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