Sr. Principal, Advisor, Sr. Advisor - Global Medicines Quality Organization

Eli Lilly and Company • Us, IN

4d

About The Position

The Sr. Principal, Advisor, Sr. Advisor is the primary quality partner for Health Economics and Outcomes Research (HEOR), covering observational and non-interventional studies, real-world data (RWD) tools and platforms, health economic modeling, literature review, and meta-analysis and data synthesis for external disclosure. The role defines and advances quality direction, interprets regulations and guidelines, maintains quality systems, assesses risk, and advises partners throughout the organization and externally.

The position provides quality oversight for HEOR’s non-interventional and real-world evidence framework, including applicable pharmacovigilance, regulatory, health technology assessment, and patient-data privacy requirements. It leads quality activities such as CAPA management, self-assessments, self-inspections, audit planning input, and IT Business Quality Assurance. The role also supports regulatory inspections and assessments, leads inspection preparation and response management, and turns lessons learned into quality-system improvements.

The role influences quality practices across functions and regions, resolves complex issues, mobilizes cross-functional and global teams, and supports business transformation and critical priorities. It also sets quality expectations for third-party partners and advises internal and external stakeholders on quality requirements and inspection needs.

Requirements

• Bachelor’s degree in a science, technology, or medically related field, or equivalent relevant work experience.
• At least 5 years of experience in quality, HEOR, real-world evidence, epidemiology, or a related pharmaceutical research discipline.
• Extensive knowledge of GxP regulations, guidelines, and standards.
• Project management experience.
• Excellent communication, interpersonal, organizational, and negotiation skills.
• Global perspective and experience working across functional and geographical boundaries.
• Demonstrated ability to identify root causes, manage difficult global business and quality issues, and distinguish critical from non-critical issues.
• Excellent problem-solving skills and initiative.
• Proficient written and spoken English.

Nice To Haves

• Familiarity with secondary use of health data and associated privacy and data governance requirements.
• Demonstrated ability to work across multiple quality portfolios and adapt to shifting business priorities.
• Knowledge of the international regulatory framework and strong knowledge of quality systems.

Responsibilities

• Interpret regulations and guidelines, define quality direction, and provide direct input into quality systems to meet internal and external expectations.
• Provide quality oversight for HEOR’s non-interventional and real-world evidence framework, including applicable GVP, ENCePP, EU PAS Register, FDA real-world evidence, HTA methodology, and patient-data privacy requirements.
• Apply quality expectations for real-world evidence methodology, including analysis pre-specification, protocol approval and registration before conduct, data-source fitness-for-purpose assessment, traceability of key study decisions, and independent quality review of deliverables.
• Conduct ongoing risk assessments, identify compliance and performance gaps, analyze data for emerging issues and trends, and recommend corrective actions.
• Manage CAPAs, deviations, change management, root-cause investigations, and corrective and preventive actions; document, escalate, and complete them, and report issues through NTM when appropriate.
• Provide input to GQA audit plans based on signals, risks, and gaps.
• Define, execute, and document quality self-assessments and self-inspections, and discuss findings with business partners.
• Serve as BQA, including IT Business Quality responsibilities under Computer System Policies and Procedures; review and approve system development and maintenance documentation and partner with IT and the business on system initiatives and changes.
• Provide HEOR quality consultation across Clinical Development, Global Patient Safety, Global Regulatory Affairs, Medical Affairs, Market Access, Legal, Privacy, and Information Technology.
• Lead pre-inspection preparation and educate internal and external business partners on inspection management and expectations.
• Support regulatory inspections and assessments, including backroom and front room support, and support audits and inspections across the broader GMQO portfolio as business needs require.
• Manage audit and inspection responses through resolution and translate lessons learned into quality-system improvements.
• Lead quality direction for HEOR and work with other consultants to promote consistent practices.
• Engage and influence leadership, lead teams to resolve complex issues and prevent recurrence, and support change management and business transformation.
• Lead harmonization of best practices across regions, functions, and Quality organizations; mobilize cross-functional and global teams and apply project planning to deliver workable solutions.
• Lead resolution of complex issues, including conflict resolution, and manage interfaces to ensure issues are closed.
• Escalate issues to management with well-developed solutions and clear action plans, including issues that could affect critical business areas.
• Set quality expectations for third-party partners, advise on requirements and inspection needs, and manage audits and inspections across regions and with external partners.

Benefits

• Company bonus, depending in part on company and individual performance.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time off and leave of absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior