Position Brand Description:The Global ATMPS (Advanced Therapy Medicinal Products) Quality Leader provides administrative and technical leadership for Cell and Gene Therapy (CGT) quality across the Lilly enterprise. This role is responsible for establishing and executing the quality strategy for CGT modalities - including AAV gene therapy, cell therapy, and LNP-based platforms - from clinical development through commercialization. The individual provides oversight of quality assurance and quality control functions for Product Research and Development, the LP2 Lebanon facility, external collaboration partners / contract manufacturers and across acquired company quality organizations, ensuring compliance with Global Quality Standards (GQS), current Good Manufacturing Practices (GMP), and applicable regulatory requirements.
This leader will build and scale a streamlined ATMP quality organization with deep modality expertise, providing quality system, regulatory submission, and inspection support to enable seamless clinical and commercial supply. The role collaborates with Quality, Product Research and Development (PR&D), LRM (Lilly Regenerative Medicine), Manufacturing, Technical Services/Manufacturing Sciences (TS/MS), Device Development, Regulatory and external collaboration partners to ensure quality and compliance requirements are met across internal sites and the external CDMO network. The organization is designed to be scalable to accommodate additional modalities as the portfolio evolves.
Key Objectives/Deliverables:1. Quality Functions and Systems OversightResponsible for the management oversight of the GMP QA and QC units supporting CGT modalities, including the LP2 commercial manufacturing site and acquired company quality organizations. Collaborate with PR&D, LRM, Manufacturing, TS/MS, Device Development, Regulatory, Global Quality Groups, CDMOs, suppliers, and analytical service providers to ensure compliance is met and maintained. Lead improvement initiatives related to quality systems, implementation of new Quality Standards, and monitoring the effectiveness of the Quality System. Ensure cGMP compliance through establishment and utilization of appropriate quality systems tailored to the unique requirements of CGT manufacturing, while considering additional modalities as the portfolio evolves. Define strategies from facility design through commercialization ensuring alignment with GQS, cGMP, and regulatory requirements. Provide key support for business development activities including quality due diligence for CGT-related acquisitions and partnerships. Serve as the accountable quality governance lead for CGT, holding final quality decision rights on CGT quality matters - including quality sign-off of CGT regulatory submissions (e.g., IND, BLA, MAA CMC/quality content), approval of the CGT quality strategy and quality systems, and qualification/disqualification decisions for CDMOs, suppliers, and external collaboration partners.
2. Quality Leadership and Modality ExpertiseProvide quality oversight and guidance for CGT modalities across the enterprise, serving as the primary point of contact with senior management for escalation of quality issues. Support and advise business personnel across functional areas including Development, LRM, TS/MS, Manufacturing, Device Development and Manufacturing Quality. Ensure appropriate decisions are made with regard to escalated issues. This includes ensuring that QA review and/or approval occurs for various GMP documents including qualification documents, change controls, specifications, stability protocols, deviations, OOS/OOT results, batch release (API and drug product), and audit-related documents in a timely fashion to support both clinical trial and commercial supply needs. Provide guidance on facility design, commissioning and qualification, asset verification, and process validation for CGT manufacturing facilities.
3. Organization Development and People LeadershipResponsible for building, scaling, and leading the Global CGT Quality organization, including direct reports at the M3, R5-R8 levels and integration of acquired company quality leads. Develop QA/QC personnel to ensure that site quality units can maintain a state of compliance with all quality expectations and foster a quality culture. Manage resourcing plans, audit plans for internal and external sites, and ensure sites remain qualified to execute their operations under cGMP. Develop people through performance management, development plans, coaching, mentoring, and challenging assignments. Establish and maintain appropriate QA and QC functionality, sufficiently capable through a combination of education, experience, and training to execute roles and responsibilities across analytical stewardship (LNP, AAV), batch release, supplier/material QA, clinical manufacturing QA, and commercial QA/QC functions. Represent Lilly externally within the ATMP quality community - participating in industry conferences, forums, and consortia - to monitor emerging trends, share best practices, and keep the organization at the leading edge of ATMP quality.
4. Compliance, Regulatory Liaison, and Audit ReadinessServe as liaison between Lilly and regulatory agencies for CGT quality matters and provide leadership during regulatory inspections at designated sites. Ensure overall support and logistics for internal and external audits. Partner with sites to maintain a state of inspection readiness and ensure coordination and preparation of pre-approval inspections. Author/approve responses and commitments made to address inspection findings and communicate/escalate issues when appropriate. Provide quality system and regulatory submission support to enable seamless clinical and commercial market supply. Ensure alignment between corporate and site quality standards and commitments across the CGT network.
5. Strategic and Business PlanningProvide budget and strategic/business planning oversight for the CGT quality organization. Participate in site business and strategic planning, review metrics, and develop Quality Plans for continuous improvement. Leverage technology and data governance to advance quality within the CGT network. Ensure robust integration of quality operations for acquired company assets, establishing efficient business processes that foster productivity across a growing and evolving organization. Design and set quality objectives aligned with the CGT portfolio's clinical and commercial milestones.
Minimum Requirements:- Minimum of a Bachelor's Degree in a science-related field such as Chemistry, Biological Sciences, Microbiology, Engineering, or related Life Sciences.
- Minimum of 15 years of experience in GMP manufacturing or quality operations within the pharmaceutical or biotechnology industry.
- Minimum of 5 years of quality leadership experience with demonstrated ability to manage regulatory communications and inspections.
- Previous QA experience with biologics, cell therapy, gene therapy (AAV), or related advanced therapy modalities.
- Demonstrated strong leadership skills with the ability to build and scale organizations.
- An understanding of the requirements of regulatory agencies such as the FDA, EMA, ICH, and other global health authorities, particularly in the area of cGMPs for biological and advanced therapy medicinal products.
- Demonstrated solid judgment, initiative, and ability to organize and prioritize multiple tasks across a complex, matrixed organization.
- Must exhibit strong teamwork, communication, and interpersonal skills with the ability to influence cross-functionally and externally.
Additional Preferences:- Advanced degree (M.S., Ph.D., or Pharm.D.) in a relevant scientific discipline.
- Previous experience in QC, analytical development, TS/MS, or Regulatory Affairs.
- Direct experience with CGT manufacturing processes including viral vector production, cell processing, and/or LNP formulation.
- Experience with facility design, commissioning, qualification, and process validation for new manufacturing sites.
- Experience with quality integration following mergers, acquisitions, or partnership onboarding.
- Demonstrated technical writing ability and proficiency with quality management systems.
- Experience leading geographically distributed teams across multiple sites.
Education Requirements: Minimum of a Bachelor's Degree in a science-related field such as Chemistry, Biological Sciences, Microbiology, Engineering, or related Life Sciences.
Other Information:- Travel: approximately 15-20%
- Position is based in Indianapolis with periodic presence required at the Lebanon, IN (LP2) facility and travel to acquired company sites as needed.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$241,500 - $354,200
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.
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