Associate Director - Document & Records Management Process Lead
Eli Lilly and Company, Indianapolis, IN, United States
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, whose employees worldwide 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 put people first, welcoming those 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.
Key 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.
Develop communication and engagement strategy.
Create a decision‑making framework for future process enhancements.
Establish 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.
Engage with program/project leaders and sponsors to align priorities, elevate 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.
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 teams to align strategy and execution, recognizing the 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.
Document and distribute agendas, minutes, decisions, and action items with weekly status reviews alongside project and workstream leaders.
Identify interdependencies, risks, and remediation plans; facilitate 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.
Basic Qualifications 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.
Additional Skills/Preferences 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.
Additional Information Ability to travel domestically and internationally as required. Fluency in English required; additional languages preferred.
Compensation Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $115,500 - $169,400. Full‑time equivalent employees are also eligible for a company bonus (depending in part on company and individual performance). Lilly offers a comprehensive benefit program, including a company‑sponsored 401(k), pension, vacation benefits, medical, dental, vision, and prescription drug benefits, flexible benefits, life insurance, death benefits, time‑off and leave of absence benefits, and well‑being benefits such as an 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.
Equal Opportunity Statement 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.
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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.
Key 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.
Develop communication and engagement strategy.
Create a decision‑making framework for future process enhancements.
Establish 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.
Engage with program/project leaders and sponsors to align priorities, elevate 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.
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 teams to align strategy and execution, recognizing the 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.
Document and distribute agendas, minutes, decisions, and action items with weekly status reviews alongside project and workstream leaders.
Identify interdependencies, risks, and remediation plans; facilitate 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.
Basic Qualifications 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.
Additional Skills/Preferences 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.
Additional Information Ability to travel domestically and internationally as required. Fluency in English required; additional languages preferred.
Compensation Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $115,500 - $169,400. Full‑time equivalent employees are also eligible for a company bonus (depending in part on company and individual performance). Lilly offers a comprehensive benefit program, including a company‑sponsored 401(k), pension, vacation benefits, medical, dental, vision, and prescription drug benefits, flexible benefits, life insurance, death benefits, time‑off and leave of absence benefits, and well‑being benefits such as an 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.
Equal Opportunity Statement 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.
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