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

Regulatory Toolkit; Indianapolis (IN); On-site; USD 66,000 - 119,000; Full time

Benefits offered by this job

401(k) match

Pension

Vacation benefits

Medical/Dental/Vision benefits

Flexible benefits

Life insurance

Time off & leave

Well-being program

Job summary

Lilly, headquartered in Indianapolis, Indiana, seeks a Senior Quality role focused on HEOR and global quality assurance. The position emphasizes interpreting regulations, ensuring compliance, and leading CAPA and inspection readiness across regulatory and cross-functional teams.

Ideal candidates will have a strong background in GxP, project management, and English communication, with 5+ years in quality or related pharmaceutical research.

Qualifications

• Bachelor’s Degree in a science, technology or medically related field or equivalent relevant work experience.
• At least 5 years’ experience in quality, health economics and outcomes research, real world evidence, epidemiology, or a related pharmaceutical research discipline.
• Extensive knowledge of GxP regulations, guidelines, and standards.
• Project management experience.

Responsibilities

• Interprets regulations and guidelines, defines quality direction, and provides direct input into quality systems to meet internal and external expectations.
• Applies quality expectations specific to RWE methodology and pre-specification of analyses, protocol approval, and registration prior to conduct.
• Performs ongoing risk assessment to identify performance and compliance gaps against current regulations, company standards, and internal procedures.

Skills

Quality Assurance

GxP Knowledge

Project Management

English Proficiency

Education

Bachelor's Degree in Science/Tech or related field

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Primary Responsibilities

• Interprets regulations and guidelines, defines quality direction, and provides direct input into quality systems to meet internal and external expectations. For HEOR this includes the non-interventional and real world evidence (RWE) framework: Good Pharmacovigilance Practices (GVP) Module VIII (Post-Authorisation Safety Studies), European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) standards, European Union Post-Authorisation Study (EU PAS) Register expectations, United States Food and Drug Administration (FDA) real world evidence guidance, Health Technology Assessment (HTA) methodological requirements, and data privacy regulation governing secondary use of patient data.
• Applies quality expectations specific to RWE methodology — pre-specification of analyses, protocol approval and registration prior to conduct, fit-for-purpose assessment of data sources, traceability of key study decisions, and independent quality review of deliverables.
• Performs ongoing risk assessment to identify performance and compliance gaps against current regulations, company standards, and internal procedures, and recommends robust corrective actions.
• Analyzes data proactively to identify emerging issues, trends, and improvement opportunities.
• Expert in corrective and preventive action (CAPA) management; ensures deviations, change management, root cause investigation, and corrective/preventive actions are managed, documented, escalated, and completed.
• Reports issues through Notification to Management (NTM) as appropriate.
• Provides input into Global Quality Auditing (GQA) audit plans based on identified signals, risks, and gaps.
• Defines, executes, and documents quality self-assessments and self-inspections, and discusses output with business partners.
• Serves as Business Quality Assurance (BQA) — performing Information Technology (IT) Business Quality responsibilities as defined in Computer System Policies and Procedures, reviewing and approving system development and maintenance documentation, and partnering with IT and the business on system related initiatives and changes.
• Provides quality consultation for HEOR, interacting at all levels across Clinical Development, Global Patient Safety, Global Regulatory Affairs, Medical Affairs, Market Access, Legal, Privacy, and Information Technology.

Inspection Readiness and Inspection Management

• Leads pre-inspection preparation and educates internal and external business partners on inspection management and expectations.
• Supports regulatory inspections and assessments, including backroom and frontroom support. HEOR activities are most commonly examined through pharmacovigilance inspections and through health authority and HTA scrutiny of submitted evidence; the role also supports inspections and audits across the broader Global Medical Quality Organization (GMQO) portfolio, including regulatory affairs and pharmacovigilance, as business need requires.
• Manages audit and inspection responses through resolution and translates lessons learned into quality system improvements.

Influence Quality Direction

• Partners effectively across Clinical Development and Pharmacovigilance, recognizing that HEOR evidence contributes to benefit-risk understanding and post-Authorisation commitments.
• Leads the direction of quality for HEOR and works with other consultants to ensure consistent practices are employed.
• Engages and influences leadership across organizations to resolve complex issues, and leads teams to deliver innovative solutions that prevent recurrence.
• Supports change management and business transformation in the delivery of critical business priorities.
• Leads harmonization of best practices across regions, functions, and other Quality organizations.
• Mobilizes cross-functional and global teams to deliver projects, applying project planning to build simple, workable solutions.

Problem Solving

• Leads resolution of complex issues, including conflict resolution, and manages interfaces to ensure issues are closed.
• Raises issues to management with well-developed solutions and clear action plans, including issues with potential to impact critical business areas.

Customer/External Focus

• Sets quality expectations for third party partners and advises on requirements and inspection needs.
• Acts as quality expert consultant to the business and external parties, and manages audits and inspections across regions and with external partners.

Minimum Qualification Requirements

• Bachelor’s Degree in a science, technology or medically related field or equivalent relevant work experience.
• At least 5 years’ experience in quality, health economics and outcomes research, real world evidence, epidemiology, or a related pharmaceutical research discipline.
• Extensive knowledge of GxP regulations, guidelines, and standards.
• Project management experience.

Other Information/Additional Preferences

• 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.
• Excellent communication, interpersonal, organizational, and negotiation skills.
• Global perspective and experience working across functional and geographical boundaries.
• Demonstrated ability to identify root cause and manage difficult global business and quality issues, and to separate critical from non-critical issues.
• Excellent problem-solving skills and initiative.
• Proficient written and spoken English language skills.

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $66,000 - $118,800. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).

• company-sponsored 401(k)
• pension
• vacation benefits
• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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