Sr. Director - Quality Business Development

Sr. Director - Quality for Business Development

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 Global Auditing and Compliance (GQAAC) team is a strategic partner, driving Lilly’s ability to expand into new business ventures with confidence and speed. By shaping the selection and adoption of quality oversight models, GQAAC ensures that innovation is built on a foundation of compliance and excellence. Through proactive engagement in quality due diligence, the team accelerates decision‑making and mitigates risk, delivering insights that strengthen acquisitions and partnerships.

This strategic approach positions Lilly for sustainable growth and competitive advantage in a rapidly evolving market.

The Sr. Director will serve as the corporate Quality representative on the Corporate Strategy and Business Development (CSBD) Linkage Hub, ensuring proactive networking with Quality senior management and executive leadership regarding potential inbound and outbound innovation activities. The Sr. Director will also lead and actively manage External Innovation due diligence assessments and GQAAC audits as applicable.

• Closely partner with other Process Owners and functional leaders to define compliance and business requirements, and design efficient and compliant processes that utilize risk management principles.
• Leverage drug development expertise, commercial manufacturing, and industry best practices to influence operational strategy and design processes that meet overall GQAAC quality audit and compliance program performance objectives.
• Evolve processes to match the changing business processes to ensure clarity of process inputs, outputs, and dependencies, and role accountability for critical steps and decisions.
• Serve as the Corporate Quality representative on the CSBD Linkage Hub.
• Perform quality system maturity, compliance history, and regulatory compliance risk profile assessments.
• Evaluate comprehensive assessment of potential acquisitions and licensing opportunities and deliver clear, actionable recommendations to inform deal decisions.
• Provide quality support for each External Innovation due diligence project and coordinate completion and networking of all GCP, GLP, and GMP reports to quality management, including a consolidated quality‑focused risk summary for the project if necessary.
• Represent quality in kickoff and information‑gathering External Innovation due diligence meetings and represent appropriately networked quality opinions in alignment and integration meetings.
• Participate in External Innovation due diligence site visits, eData rooms, and subsequent audits as appropriate.
• Escalate significant concerns noted in business development due diligence activities to senior management following a risk‑based consideration.
• Assure and partner with the appropriate quality area SME is involved in each business development due diligence activity to include GCP, GLP, and GMP where appropriate.
• Serve as a liaison and provide quality and compliance insights during negotiations with the commercial business development team to ensure that Quality is represented in business deals related to the purchase of new facilities.
• Review and provide quality perspectives/ comments for contracts resulting from new business development opportunities and new line additions associated with existing collaborations.

• Bachelor’s Degree in a science‑related field.
• Deep knowledge of global regulatory frameworks (FDA, EMA, ICH, etc.).
• Strong business acumen and ability to influence at senior levels.
• Exceptional analytical,…