Sr. Director - Quality for Business Development

Role Summary

The Sr. Director - Quality for Business Development serves as the corporate Quality representative on the Corporate Strategy and Business Development linkage, driving proactive quality oversight for inbound and outbound innovation. The role leads External Innovation due diligence, quality assessments, and audits, ensuring risk-based Quality requirements are built into contracting and deal negotiations. It collaborates with GQAAC Management and leadership across Lilly Research Laboratories, PRD, Procurement, Legal, and other functions to support enterprise strategy, portfolio management, and partnerships in a rapidly evolving market.

Responsibilities

• Quality Process Owner for Business Development: define compliance and business requirements with stakeholders to design efficient, compliant processes using risk management principles.
• Leverage drug development expertise, manufacturing knowledge, and industry best practices to influence operational strategy and design processes that meet quality program objectives.
• Evolve processes to reflect changing business processes, clarifying inputs/outputs/dependencies and role accountability.
• Serve as Corporate Quality representative on the CSBD Linkage Hub.
• Perform quality system maturity, compliance history, and regulatory risk profiling.
• Evaluate potential acquisitions and licensing opportunities; deliver actionable recommendations to inform deal decisions.
• Provide quality support for External Innovation due diligence projects; coordinate GCP/GLP/GMP reports and a quality risk summary as needed.
• Represent quality in kickoff and information-gathering due diligence meetings; contribute quality opinions in alignment and integration discussions.
• Participate in external due diligence site visits, eData rooms, and subsequent audits as appropriate.
• Escalate significant concerns from due diligence activities to senior management using risk-based considerations.
• Engage appropriate SME involvement in each due diligence activity, including external experts as needed.
• Act as a liaison to provide quality and compliance insights during negotiations to ensure Quality is represented in deals involving new facilities or collaborations.
• Review and provide quality perspectives on contracts arising from new opportunities and existing collaborations.

Qualifications

• Required: Bachelor’s 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 auditing, and/or regulatory inspections.
• Required: Minimum 10 years of experience in relevant GXP areas or associated supporting functions.
• Required: Proven experience in merger and acquisition, strategic partnerships, and oversight of vendors/Third Party Organizations within the pharmaceutical/biotech industry.
• Required: Successful track record at senior management level.
• Required: Ability to work in a dynamic environment and manage complexity.
• Preferred: Demonstrated ability to drive and lead cross-functional change.
• Preferred: Experience across multiple facets of drug development and/or pharmaceutical project management.

Education

• Bachelor’s Degree in a science-related field; advanced degree preferred

Additional Requirements

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