AVP - Global ATMP Quality

Key Objectives/Deliverables

1. Quality Functions and Systems Oversight

• Responsible 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 Expertise

• Provide 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 Leadership

• Responsible 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 Readiness

• Serve 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 Planning

• Provide 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.