Associate Director - Document & Records Management Process Lead
Eli Lilly and Company
4 months ago
Remote friendly (Indianapolis, IN)
United States
Operations
Role Overview
The Associate Director, Process Lead for Document and Records Management is a P4-level leader within Global Quality Systems (GQS) accountable for the design, implementation, and sustainment of Lilly’s global Documentation and Records Management process.
Key Responsibilities
- Support establishment, maintenance, and evolution of the global Documentation and Records Management Quality System; drive standardization and simplification.
- Own assigned components of the Quality Manual, global standards, procedures, tools, resources, and/or training aligned to regulatory expectations, industry standards, and company policies.
- Ensure consistent global execution of document management processes; identify gaps, risks, and trends via performance signal monitoring.
- Support Quality System Architecture, including periodic reviews and lifecycle governance for assigned processes.
- Chair or participate in global document review boards for creation, revision, and lifecycle management of quality documents.
- Design, launch, and mature the Documentation and Records Management Global Process Forum (operating norms/governance, communication/engagement, decision-making framework, leadership/trust/prioritization).
- Lead a global network of Area Process Owners (APOs) across QMS pillars (Quality Governance, Lifecycle Management, Operational Controls).
- Engage program/project leaders and sponsors to align priorities, escalate risks, and drive execution.
- Analyze process performance data; define/maintain global effectiveness and efficiency metrics; recommend continuous improvement.
- Act as a process and systems SME partnering with IT/analytics; ensure enabling systems are configured/optimized.
- Partner with GPOs and enterprise teams to harmonize global quality processes and shared GQS objectives.
- Interface with QMS Governance to support oversight and effectiveness of the GPO/APO network.
- Support inspection readiness (including Health Authority inspections) and contribute to responses for documentation/records observations.
- Monitor regulatory/industry trends and escalate emerging risks/changes.
- Provide program/project management for global initiatives (plans, timelines, PM tools; agendas/minutes/decisions/action items; weekly status reviews; manage interdependencies/risks/remediation; facilitate decision forums; advise on analyses and recommendations; manage workstreams/tasks; support learning/curriculum).
Basic Qualifications
- Bachelor’s degree in Business, Physical/Natural Science, Engineering, Pharmacy, or another Life Science-related discipline.
- Experience in pharmaceutical/regulated life sciences in GxP-related roles.
- Experience supporting/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/development).
- Experience developing or sustaining standardized, scalable global processes.
Additional Skills/Preferences
- Proactively identify opportunities, risks, and issues; lead continuous improvement.
- Enterprise mindset; understanding of broader portfolio strategy and external regulatory landscape.
- Influence without authority; drive action and accountability.
- Independent operation with sound judgment; escalate appropriately.
- Communicate clearly and effectively across all levels.
Additional Information
- Ability to travel domestically and internationally as required.
- Fluency in English required; additional languages preferred.
- Anticipated compensation: $115,500 - $169,400. Full-time employees may be eligible for a company bonus.
- Benefits may include 401(k), pension, vacation, medical/dental/vision/prescription coverage, flexible benefits (e.g., healthcare/dependent day care FSAs), life insurance, time off/leave benefits, and well-being benefits (e.g., employee assistance, fitness benefits, employee clubs/activities).
- Application instruction (accommodation): If you need accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation
The Associate Director, Process Lead for Document and Records Management is a P4-level leader within Global Quality Systems (GQS) accountable for the design, implementation, and sustainment of Lilly’s global Documentation and Records Management process.
Key Responsibilities
- Support establishment, maintenance, and evolution of the global Documentation and Records Management Quality System; drive standardization and simplification.
- Own assigned components of the Quality Manual, global standards, procedures, tools, resources, and/or training aligned to regulatory expectations, industry standards, and company policies.
- Ensure consistent global execution of document management processes; identify gaps, risks, and trends via performance signal monitoring.
- Support Quality System Architecture, including periodic reviews and lifecycle governance for assigned processes.
- Chair or participate in global document review boards for creation, revision, and lifecycle management of quality documents.
- Design, launch, and mature the Documentation and Records Management Global Process Forum (operating norms/governance, communication/engagement, decision-making framework, leadership/trust/prioritization).
- Lead a global network of Area Process Owners (APOs) across QMS pillars (Quality Governance, Lifecycle Management, Operational Controls).
- Engage program/project leaders and sponsors to align priorities, escalate risks, and drive execution.
- Analyze process performance data; define/maintain global effectiveness and efficiency metrics; recommend continuous improvement.
- Act as a process and systems SME partnering with IT/analytics; ensure enabling systems are configured/optimized.
- Partner with GPOs and enterprise teams to harmonize global quality processes and shared GQS objectives.
- Interface with QMS Governance to support oversight and effectiveness of the GPO/APO network.
- Support inspection readiness (including Health Authority inspections) and contribute to responses for documentation/records observations.
- Monitor regulatory/industry trends and escalate emerging risks/changes.
- Provide program/project management for global initiatives (plans, timelines, PM tools; agendas/minutes/decisions/action items; weekly status reviews; manage interdependencies/risks/remediation; facilitate decision forums; advise on analyses and recommendations; manage workstreams/tasks; support learning/curriculum).
Basic Qualifications
- Bachelor’s degree in Business, Physical/Natural Science, Engineering, Pharmacy, or another Life Science-related discipline.
- Experience in pharmaceutical/regulated life sciences in GxP-related roles.
- Experience supporting/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/development).
- Experience developing or sustaining standardized, scalable global processes.
Additional Skills/Preferences
- Proactively identify opportunities, risks, and issues; lead continuous improvement.
- Enterprise mindset; understanding of broader portfolio strategy and external regulatory landscape.
- Influence without authority; drive action and accountability.
- Independent operation with sound judgment; escalate appropriately.
- Communicate clearly and effectively across all levels.
Additional Information
- Ability to travel domestically and internationally as required.
- Fluency in English required; additional languages preferred.
- Anticipated compensation: $115,500 - $169,400. Full-time employees may be eligible for a company bonus.
- Benefits may include 401(k), pension, vacation, medical/dental/vision/prescription coverage, flexible benefits (e.g., healthcare/dependent day care FSAs), life insurance, time off/leave benefits, and well-being benefits (e.g., employee assistance, fitness benefits, employee clubs/activities).
- Application instruction (accommodation): If you need accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation