Sr. Director - Quality for Business Development

Role Summary

The Sr. Director - Quality for Business Development leads quality oversight for inbound and outbound innovation, serving as the corporate Quality representative on the CSBD linkage hub, guiding due diligence, contract reviews, and quality integration in business development activities. Responsible for managing External Innovation due diligence and GQAAC audits, and coordinating quality input across Lilly’s research, development, procurement, and commercial teams to enable informed deal decisions.

Responsibilities

• Quality Process Owner for Business Development: define compliance and business requirements with cross-functional partners and design efficient, compliant processes using risk management principles.
• Leverage drug development and manufacturing knowledge, industry best practices, benchmarking, and technology advances to influence operational strategy and design processes meeting GQAAC objectives.
• Evolve processes to reflect changing business processes, clarify inputs/outputs/dependencies, and define role accountability for key steps.
• Serve as Corporate Quality representative on the CSBD Linkage Hub.
• Perform quality system maturity, compliance history, and regulatory risk profiling.
• Evaluate acquisitions and licensing opportunities, delivering actionable recommendations to inform deal decisions.
• Provide quality support for External Innovation due diligence projects and coordinate GCP/GLP/GMP reports with a consolidated risk summary as needed.
• Represent quality in kickoff and information-gathering due diligence meetings, providing networked quality opinions in alignment and integration sessions.
• Participate in site visits/eData rooms and subsequent audits as appropriate.
• Escalate significant concerns from due diligence to senior management using risk-based considerations.
• Ensure involvement of appropriate SME quality experts (GCP/GLP/GMP) in each due diligence activity, including external firms if needed.
• Act as a liaison providing quality and compliance insights during negotiations to ensure Quality is represented in deals involving new facilities.
• Review and provide quality perspectives on contracts from new business development opportunities and existing collaborations.

Qualifications

• Required: Bachelor‚Äôs Degree in a science-related field.
• Required: Deep knowledge of global regulatory frameworks (FDA, EMA, ICH, etc.).
• Required: Strong business acumen and ability to influence at senior levels.
• Required: Exceptional analytical, negotiations, and communication skills.
• Required: Proven ability to synthesize information from multiple sources and make risk-based decisions.
• Required: Cross-functional collaboration and integration planning skills.
• Required: Minimum 10 years of experience in auditing/overseeing audits and/or regulatory inspections.
• Required: Minimum 10 years of experience in relevant GXP areas or related supporting functions.
• Required: Proven experience in merger and acquisition, strategic partnerships, and overseeing vendors/Third Party Organizations within the pharmaceutical/biotech industry.
• Required: Successful track record at senior management level.
• Required: Ability to work in a dynamic, complex environment.
• Preferred: Demonstrated ability to drive and lead cross-functional change.
• Preferred: Experience across multiple facets of drug development and/or pharmaceutical project management.
• Education: Advanced degree is preferred.

Skills

• Quality governance and risk management
• Regulatory compliance and due diligence
• Contract review and negotiation
• Cross-functional leadership and stakeholder management
• Strategic thinking and analytical decision-making

Education

• Bachelor‚Äôs Degree in a science-related field; advanced degree preferred

Additional Requirements

• Domestic and international travel is required to fulfill these job responsibilities. Must be able to travel up to 20%, sometimes on short notice.