AVP - Global ATMP Quality

Lilly • Indianapolis, IN

1d • $247,500 - $363,000 • Onsite

About The Position

The Global ATMP Quality Leader provides administrative and technical leadership for cell and gene therapy (CGT) quality across Lilly. The role establishes and executes quality strategy for AAV gene therapy, cell therapy, and LNP-based platforms from clinical development through commercialization. It oversees quality assurance and quality control for Product Research and Development, the LP2 Lebanon facility, external collaboration partners and contract manufacturers, and acquired company quality organizations, ensuring compliance with Lilly Global Quality Standards, current Good Manufacturing Practices, and applicable regulatory requirements.

The leader builds and scales a streamlined ATMP quality organization with modality expertise, providing quality-system, regulatory-submission, and inspection support for clinical and commercial supply. The position collaborates across Quality, PR&D, LRM, Manufacturing, TS/MS, Device Development, Regulatory, and external partners. The organization is intended to scale as the portfolio and modalities evolve.

The role has final quality decision rights for CGT matters, including quality sign-off on regulatory submissions, approval of quality strategy and systems, and qualification or disqualification decisions involving CDMOs, suppliers, and external partners. It leads quality governance, supports regulatory communications and inspections, develops the organization and its people, oversees strategic and budget planning, and advances quality through technology, data governance, and continuous improvement. The position is based in Indianapolis, with periodic presence at the Lebanon, Indiana LP2 facility and travel to acquired company sites as needed. Travel is approximately 15–20%.

Requirements

• Bachelor’s degree or higher in a science-related field such as Chemistry, Biological Sciences, Microbiology, Engineering, or related Life Sciences.
• At least 15 years of experience in GMP manufacturing or quality operations within the pharmaceutical or biotechnology industry.
• At least 5 years of quality leadership experience, including demonstrated ability to manage regulatory communications and inspections.
• Previous QA experience with biologics, cell therapy, gene therapy (AAV), or related advanced therapy modalities.
• Demonstrated leadership skills and ability to build and scale organizations.
• Understanding of FDA, EMA, ICH, and other global health authority requirements, particularly cGMP requirements for biological and advanced therapy medicinal products.
• Solid judgment, initiative, and ability to organize and prioritize multiple tasks in a complex, matrixed organization.
• Strong teamwork, communication, and interpersonal skills, with ability to influence cross-functionally and externally.

Nice To Haves

• Advanced degree (M.S., Ph.D., or Pharm.D.) in a relevant scientific discipline.
• 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 integrating quality following mergers, acquisitions, or partnership onboarding.
• Demonstrated technical writing ability and proficiency with quality management systems.
• Experience leading geographically distributed teams across multiple sites.

Responsibilities

• Oversee GMP QA and QC units supporting CGT modalities, including the LP2 commercial manufacturing site and acquired company quality organizations.
• Collaborate with internal functions, CDMOs, suppliers, and analytical service providers to establish and maintain compliance.
• Lead quality-system improvement initiatives, implement Quality Standards, and monitor quality-system effectiveness.
• Establish CGT-appropriate quality systems and define quality strategies from facility design through commercialization.
• Provide quality due diligence for CGT-related acquisitions and partnerships.
• Serve as accountable CGT quality governance lead, with final quality decision rights on CGT quality matters, including regulatory submission sign-off, quality strategy and system approval, and qualification or disqualification decisions for external partners and suppliers.
• Provide enterprise-wide quality oversight and guidance for CGT modalities and serve as the primary senior-management contact for escalated quality issues.
• Ensure timely QA review or approval of GMP documents, including qualification documents, change controls, specifications, stability protocols, deviations, OOS/OOT results, batch release, and audit-related documents.
• Guide facility design, commissioning and qualification, asset verification, and process validation for CGT manufacturing facilities.
• Build, scale, and lead the Global CGT Quality organization, including direct reports and integration of acquired company quality leads.
• Develop QA/QC personnel and foster a quality culture; manage resourcing plans and internal and external audit plans, and ensure sites remain qualified to operate under cGMP.
• Lead performance management, development planning, coaching, mentoring, and challenging assignments for personnel.
• Establish appropriate QA and QC capabilities across analytical stewardship, batch release, supplier and material QA, clinical manufacturing QA, and commercial QA/QC.
• Represent Lilly in the external ATMP quality community through conferences, forums, and consortia.
• Liaise with regulatory agencies on CGT quality matters and lead regulatory inspections at designated sites.
• Coordinate internal and external audit support and logistics, maintain inspection readiness, and prepare for pre-approval inspections.
• Author or approve responses and commitments addressing inspection findings and communicate or escalate issues as appropriate.
• Provide quality-system and regulatory-submission support for clinical and commercial supply, and align corporate and site quality standards across the CGT network.
• Oversee CGT quality organization budget and strategic/business planning; participate in site planning, review metrics, and develop continuous-improvement Quality Plans.
• Use technology and data governance to advance quality across the CGT network.
• Integrate quality operations for acquired company assets and establish efficient business processes.
• Design quality objectives aligned with CGT portfolio clinical and commercial milestones.

Benefits

• Company bonus, depending in part on company and individual performance.
• Company-sponsored 401(k) eligibility.
• Pension.
• Vacation benefits.
• Medical, dental, vision, and prescription drug benefit eligibility.
• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive