Sr. Director - Quality for Business Development

Eli Lilly and Company • Indianapolis, IN

14d

About The Position

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. Position Brand Description: 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 position serves as the corporate Quality representative on the Corporate Strategy and Business Development (CSBD) Linkage Hub and is responsible for ensuring proactive networking with Quality Sr. management and executive leadership regarding potential relevant inbound and outbound innovation activities as well as representing Quality in Business Development Contract reviews to ensure the appropriate risk-based Quality requirements are built into the contracting process. The Sr. Director will also lead and/or actively manage External Innovation due diligence assessments and GQAAC audits as applicable. Key Objectives/Deliverables: This role oversees Quality activities for both inbound and outbound innovation, which supports an important aspect of enterprise strategy, innovation, and portfolio management. The Sr. Director will work closely with GQAAC Management, and partner with executives, senior management and functional leaders across Lilly Research Laboratories (LRL), Business Units, Product Research & Development (PRD), Procurement, and others. Quality Process Owner for Business Development Closely partners with other Process Owners, functional leaders, subject matter experts (SMEs), Quality, External Sourcing, Procurement, Compliance and Legal to define applicable compliance and business requirements, and to design efficient and compliant processes that utilize risk management principles. Leverages drug development expertise, commercial manufacturing and knowledge of internal and external requirements, industry best practices and benchmarking, new capabilities, and advances in technology including information flow 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 (e.g., connected processes, data standards, information flow implications, etc.), and role accountability for critical steps and decisions. Corporate Quality representative on the Corporate Strategy and Business Development (CSBD) Linkage Hub. Performs quality system maturity, compliance history and regulatory compliance risk profiles. Evaluates comprehensive assessment of potential acquisitions, and licensing opportunities and delivers clear, actionable recommendations to inform deal decisions. Provides quality support for each External Innovation due diligence project and coordinate completion and networking of all GCP, GLP and GMP reports to quality management and others as appropriate, including a consolidated quality focused risk summary for the project if necessary. Represents quality in kick off and information gathering External Innovation due diligence meetings and represents appropriately networked quality opinions in alignment and integration meetings. Participates in External Innovation due diligence site visits / eData rooms and subsequent audits as appropriate. Escalates significant concerns noted in business development due diligence activities to senior management following a risk-based considerations. Assures and partners with the appropriate quality area Subject Matter Experts (SME) is involved in each business development due diligence activity to include GCP, GLP and GMP as appropriate. This may also include working outside of GQAAC and outside of Lilly (i.e., consulting firms) to identify expertise appropriate to the specific due diligence. Serves as a liaison and provides quality and compliance insights during negotiations to the commercial business development team to ensure that Quality is represented in business deals related to purchase of new facilities. Reviews and provides quality perspectives / comments for contracts resulting from new business development opportunities and new line additions associated with existing collaborations, etc.

Requirements

• 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, negotiations and communication skills.
• Proven ability to synthesize information from multiple sources and make risk-based decisions.
• Skilled in cross-functional collaboration and integration planning.
• A minimum of 10 years of experience in auditing, overseeing auditing, and/or regulatory inspections.
• A minimum of 10 years of experience in relevant GXP areas or associated supporting functions.
• Proven experience of merger and acquisition, strategic partnership and overseeing vendors/Third Party Organizations within the pharmaceutical/biotech industry.
• Successful track record at senior management level.
• Ability to work in a dynamic environment and deal with complexity.

Nice To Haves

• Demonstrated ability to drive and lead cross-functional change.
• Experienced in multiple facets of drug development and/or pharmaceutical project management experience

Responsibilities

• Oversees Quality activities for both inbound and outbound innovation
• Works closely with GQAAC Management, and partner with executives, senior management and functional leaders across Lilly Research Laboratories (LRL), Business Units, Product Research & Development (PRD), Procurement, and others.
• Quality Process Owner for Business Development
• Closely partners with other Process Owners, functional leaders, subject matter experts (SMEs), Quality, External Sourcing, Procurement, Compliance and Legal to define applicable compliance and business requirements, and to design efficient and compliant processes that utilize risk management principles.
• Leverages drug development expertise, commercial manufacturing and knowledge of internal and external requirements, industry best practices and benchmarking, new capabilities, and advances in technology including information flow 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 (e.g., connected processes, data standards, information flow implications, etc.), and role accountability for critical steps and decisions.
• Corporate Quality representative on the Corporate Strategy and Business Development (CSBD) Linkage Hub.
• Performs quality system maturity, compliance history and regulatory compliance risk profiles.
• Evaluates comprehensive assessment of potential acquisitions, and licensing opportunities and delivers clear, actionable recommendations to inform deal decisions.
• Provides quality support for each External Innovation due diligence project and coordinate completion and networking of all GCP, GLP and GMP reports to quality management and others as appropriate, including a consolidated quality focused risk summary for the project if necessary.
• Represents quality in kick off and information gathering External Innovation due diligence meetings and represents appropriately networked quality opinions in alignment and integration meetings.
• Participates in External Innovation due diligence site visits / eData rooms and subsequent audits as appropriate.
• Escalates significant concerns noted in business development due diligence activities to senior management following a risk-based considerations.
• Assures and partners with the appropriate quality area Subject Matter Experts (SME) is involved in each business development due diligence activity to include GCP, GLP and GMP as appropriate.
• Serves as a liaison and provides quality and compliance insights during negotiations to the commercial business development team to ensure that Quality is represented in business deals related to purchase of new facilities.
• Reviews and provides quality perspectives / comments for contracts resulting from new business development opportunities and new line additions associated with existing collaborations, etc.

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Number of Employees: 5,001-10,000 employees