CMC Regulatory Quality Advisor

Company: Eli Lilly and Company
Location: Indianapolis
Posted on: December 1, 2025

Job Description:

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. The purpose of the CMC Regulatory Quality Advisor role is to be the quality expert for their given area of responsibility (regional/affiliate, portfolio and/or functional business units). This role participates in strategic planning to strengthen the quality of Safety and Efficacy Quality System (SEQS) effectiveness, and the integration of quality into business processes and is responsible for implementation of quality initiatives and providing guidance to team. Primary Responsibilities: This position provides direct quality support to Global Regulatory Affairs (GRA), with a primary focus on the Chemistry, Manufacturing, and Controls (CMC) business function. The role ensures compliance with regulatory standards and drives quality excellence across GRA processes. In addition to technical responsibilities, the position includes leadership of two direct reports, fostering a collaborative and high-performance team environment. 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 key input into the design of the Quality System and leads implementation into the business area with accountability for the implementation and delivery of milestones. Provides guidance and expectations to enable execution of regulations on a local, regional, and global level ensuring compliance and inspection readiness. Accountable for the development and implementation of the quality strategy for the portfolio and functions, partnering with business to complete quality risk assessments and develop a risk management plan. Performs on-going risk assessment and evaluation of the quality system to identify performance/compliance gaps relative to current regulations and company standards, guidelines and internal procedures and recommends robust corrective actions. Engage in proactive data analysis for the area assigned to identify emerging issues, trends, and opportunities, contributing to informed decision-making and continuous improvement. Expert in corrective and preventative actions (CAPA) management. Ensure deviation/change management, root cause investigation and corrective/preventive actions are managed, documented, escalated, and completed. Reports issues through Notification to Management (NTM) as appropriate Provides input into Global Quality Auditing and Compliance (GQAAC) audit plans based on identified signal/risks/gaps. Defines, executes, and documents quality self-assessments checks/self-inspections and discusses output with business partners. Serves as Business Quality Assurance (BQA) for critical business systems in area of responsibility. Perform responsibilities of IT Business Quality as defined in Computer System Policies and Procedures. Review and approve, as appropriate, documents associated with the development and maintenance of IT systems as the BQA. Partner with IT and the business on system related initiatives/changes as the BQA for assigned IT systems. Responsible for quality consultation for the SEQS component assigned (for example, clinical research development (protocol to disclosure) involving interactions with all levels across the organizations, including groups such as Legal, Compliance, Finance, Clinical Design, Delivery and Analytics (CDDA), etc.) 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 regulatory inspections (PV, site, and sponsor inspections). Coordinate and manage audits/inspections effectively, including backroom and front room support, as required. Responsible for audit and inspection response management, coordination, documentation, and tracking through resolution. Actively participates in lessons learned/shared learning sessions regarding clinical trial site support during inspections, as applicable to role. 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, CDDA, Regulatory, Safety, Medical Affairs, 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 critical business priorities. 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 critical business areas. 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 business area assigned. 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 advising 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 Six Sigma 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. Manages audits and regulatory inspections in cross-functional company areas, across regions and with external partners. Minimum Qualification Requirements: Bachelor’s Degree - Preferred degree in a science, technology or medically related field Minimum 5 years’ experience in pharmaceutical industry, preferred in a CMC regulatory related role Other Information/Additional Preferences: Extensive knowledge of GxP regulations, guidelines, and standards. Project management experience. Comfortable with new and developing technologies Excellent communication (written and verbal), interpersonal, organizational and negotiation skills. Global perspective and working across functional and geographical boundaries. Knowledge of the international regulatory framework. Demonstrated ability to identify root cause and manage difficult global business/quality issues. Ability to separate critical from non-critical issues. Ability to work effectively at all levels of the organization. Excellent problem-solving skills and initiative. Proficient written and spoken English language skills. Solid understanding of quality systems and CMC business processes Previous supervisory experience. Note: Employees currently on the R path or in technical-ladder-eligible roles will transition into this position at their existing R path level, consistent with global job structure criteria. 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 is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $126,000 - $204,600 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. WeAreLilly

Keywords: Eli Lilly and Company, Indianapolis , CMC Regulatory Quality Advisor, Science, Research & Development , Indianapolis, Indiana