Associate Director - QMS Lifecycle Management (R&D)

Role: Associate Director, QMS Lifecycle Management (R&D Focus)

Responsibilities:
- Partner with Global Process Owners (GPOs) for R&D-relevant processes within the QMS Lifecycle Management pillar, including Drug & Device Development, Non-Clinical/Discovery Programs, Clinical Management (trial design, site engagement, data analysis, and disclosure of research results), Global Patient Safety, and Regulatory affairs.
- Execute QMS governance and monitoring for the Lifecycle Management pillar, representing R&D needs and aligning to the global process framework.
- Coordinate day-to-day R&D lifecycle health monitoring and reporting; escalate risks, trends, and improvement opportunities to the Operational Controls Lead.
- Define, monitor, and interpret health measures for the R&D QMS process ecosystem (performance, compliance, effectiveness, user experience).
- Support adherence to global regulatory standards and internal requirements; identify gaps and escalate compliance risks and remediation needs.
- Identify and support process improvement opportunities by analyzing performance, deviations, findings, and stakeholder feedback.
- Monitor and summarize key metrics/leading indicators; provide routine reporting and actionable recommendations to GPOs, R&D stakeholders, and the Operational Controls Lead.
- Maintain stakeholder relationships; support process updates, communications, training alignment, adoption, and QMS documentation representation.
- Maintain awareness of regulatory/industry trends affecting R&D quality and coordinate interpretation/actions through governance.
- Build and maintain an inventory of R&D stakeholders; engage relevant stakeholders for each process.

Basic Requirements:
- 7+ years’ experience in the pharmaceutical industry in business, quality, or operational roles, with demonstrated understanding of R&D processes and/or clinical operations.
- Bachelor’s degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field.

Additional Skills/Preferences:
- Ability to lead in a matrixed organization and influence without direct control, especially in R&D.
- Experience supporting cross-functional or multi-site process improvement in R&D.
- Strategic thinking; ability to balance conflicting R&D priorities.
- Ability to analyze/interpret complex R&D data to drive decisions.
- Change agility in scientific and regulatory contexts.
- Strong teamwork, interpersonal, and communication skills.
- Experience building scalable, standardized global R&D processes.
- Ability to influence and partner effectively with R&D functional leads and process owners.
- Ability to balance speed, quality, and risk.
- Ability to establish governance structures and proactively address quality/regulatory risks.
- Available to travel domestically/internationally as required (~10%).

Benefits (if applicable):
- Eligible for a company bonus (depending on company and individual performance).
- Comprehensive benefit program including 401(k), pension, vacation, medical/dental/vision/prescription drug, flexible benefits, life insurance, time off/leave of absence, and well-being benefits.

Application Instructions:
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation