Associate Director - Document & Records Management Process Lead

Eli Lilly and Company • Indianapolis, IN

2d

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. 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. Role Overview The Associate Director, Process Lead for Document and Records Management is a P4‑level leader within Global Quality Systems (GQS) with accountability for elements of the design, implementation, and sustainment of Lilly’s global Documentation and Records Management process. This role delivers global process leadership, governance, and subject matter expertise to ensure documentation and records management processes are compliant, standardized, and scalable across Research, Development, Manufacturing, and Commercial operations. The Associate Director influences enterprise‑level strategy in one of Lilly’s few truly global process areas and partners closely with senior Quality leadership, QMS governance bodies, and cross‑functional stakeholders. This position offers a significant opportunity to shape the future state of Lilly’s Documentation and Records Management Process Owner Network while strengthening inspection readiness, documentation quality, and operational execution.

Requirements

• Education: Bachelor’s degree in Business, Physical or Natural Science, Engineering, Pharmacy, or another Life Science–related discipline.
• Experience: Experience in the pharmaceutical or regulated life sciences industry in GxP‑related roles.
• Experience supporting or leading global or multi‑site quality system initiatives.
• Working knowledge of global regulatory requirements and inspection expectations.
• Demonstrated people, matrix, or functional leadership, including mentoring and development of others.
• Experience developing or sustaining standardized, scalable global processes

Nice To Haves

• Proactively identify opportunities, risks, and issues.
• Lead continuous improvement.
• Demonstrate an enterprise mindset, understanding broader portfolio strategy and the external regulatory landscape.
• Influence without authority and drive others toward action and accountability.
• Operate independently with sound judgment, escalating appropriately.
• Communicate clearly, concisely, and effectively across all levels of the organization.
• Ability to travel domestically and internationally as required.
• Fluency in English required; additional languages preferred.

Responsibilities

• Global Process Execution and Governance Support the establishment, maintenance, and evolution of the global Documentation and Records Management Quality System, driving standardization and simplification across regions.
• Own assigned components of the Quality Manual, global standards, procedures, tools, resources and/or training, ensuring alignment with regulatory expectations, industry standards, and Lilly policies.
• Ensure consistent global execution of Document Management processes; identify gaps, risks, and trends through monitoring of performance signals.
• Support the Quality System Architecture, including execution of periodic reviews and lifecycle governance for assigned processes.
• Chair or participate in global document review boards to enable effective creation, revision, and lifecycle management of global quality documents.
• Process Forum & Network Leadership Design, launch, and mature the Documentation and Records Management Global Process Forum, including: Operating norms and governance model Communication and engagement strategy.
• Decision‑making framework for future process enhancements Leadership model, trust‑building mechanisms, and prioritization approach.
• Provide leadership and direction to a global network of Area Process Owners (APOs) spanning all three QMS pillars (Quality Governance, Lifecycle Management, Operational Controls).
• Engage with program/project Leaders and Sponsors to align priorities, escalate risks, and drive execution.
• Continuously evolve the Forum to a higher level of maturity, effectiveness, and enterprise value.
• Continuous Improvement, Analytics & Strategy Analyze process performance data to identify, prioritize, and recommend continuous improvement opportunities, recognizing the early stage of global standardization in Documentation and Records Management.
• Define and maintain global effectiveness and efficiency metrics; translate insights into actionable recommendations.
• Influence enterprise‑level strategy and decision‑making in Documentation and Records Management through data‑driven analysis and systems thinking.
• Introduce a Quality business leadership perspective to improve audit preparedness, inspection readiness, documentation quality, and records execution.
• Systems, Partnerships Enterprise Collaboration Act as a process and systems SME, partnering with IT and analytics teams to ensure enabling systems are configured, maintained, and optimized to meet business and reporting needs.
• Partner with the various GPOs and team to align strategy and execution, recognizing the strong interdependencies between process areas such as Personnel and Training Management, Data Integrity.
• Collaborate with enterprise and cross‑GPO teams to support harmonized global quality processes and shared GQS objectives.
• Interface with QMS Governance to support oversight and effectiveness of the GPO/APO network.
• Inspection Readiness & External Environment Support inspection readiness, including participation in Health Authority inspections and contribution to responses for observations related to Documentation and Records Management.
• Monitor regulatory and industry trends and proactively identify emerging risks or changes, escalating as appropriate.
• Program & Project Leadership Provide project and program management leadership for global initiatives, including: Development of project plans, timelines, and PM tools.
• Documentation and distribution of agendas, minutes, decisions, and action items.
• Weekly status reviews with project and workstream leads.
• Identification of interdependencies, risks, and remediation plans.
• Facilitation of forums and decision‑making meetings.
• Advise on options, strategies, and methodologies perform analyses and document recommendations.
• Manage assigned workstreams, projects, and tasks, following up with SMEs and core team members to ensure timely delivery.
• Support learning and curriculum management related to Documentation and Records Management.

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: Mid Level
• Number of Employees: 5,001-10,000 employees