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.
About the Job: At Lilly, we unite caring with discovery to make life better for people around the world. As a global healthcare leader, our employees 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. We’re looking for individuals who are determined to make life better for people around the world.
Role Overview:
The Associate Director, QMS Lifecycle Management (R&D Focus) serves as the R&D business partner within the Lifecycle Management pillar of the Quality Management System (QMS). This role supports the integrity and evolution of the QMS process framework for R&D-relevant processes by partnering with Global Process Owners (GPOs) and key stakeholders to implement standards, governance, and metrics.
The incumbent is accountable for day-to-day coordination, health monitoring, and reporting for the R&D-relevant portion of the Lifecycle Management pillar, escalating risks, trends, and improvement opportunities to the Operational Controls Lead, who provides cross-domain oversight across Commercial, Product Development, and R&D processes within the QMS.
Reporting Relationship:
This role reports to the Operational Controls Lead and partners closely with Global Process Owners and R&D stakeholders to support effective implementation and ongoing health of R&D-relevant QMS processes.
High-Level Responsibilities:
Partner with and support teams and leaders of Global Process Owners (GPOs) for R&D-relevant processes within the Lifecycle Management pillar, including:
Drug & Device Development, Non-Clinical/Discovery Programs, Clinical Management (including trial design, site engagement, data analysis, and disclosure of research results), Global Patient Safety, and Regulatory affairs according to the QMS global process framework
Governance & Strategy:
- Execute within QMS governance and monitoring models for the Lifecycle Management pillar, representing R&D needs and ensuring alignment to the global process framework.
- Partner with the Operational Controls Lead and process owners to define, monitor, and interpret health measures for the R&D-relevant QMS process ecosystem (e.g., performance, compliance, effectiveness, and user experience indicators).
- Support adherence to applicable global regulatory standards and internal requirements for R&D processes; identify gaps and escalate compliance risks, trends, and remediation needs through established governance forums.
Continuous Improvement:
- Identify and support process improvement opportunities for R&D-relevant Lifecycle Management processes by analyzing process performance, deviations, findings, and stakeholder feedback.
- Monitor and summarize key metrics and leading indicators; provide routine reporting and actionable recommendations to GPOs, R&D stakeholders, and the Operational Controls Lead.
Leadership, Collaboration & Stakeholder Engagement:
- Build and sustain strong working relationships with GPOs and the R&D stakeholder community to coordinate process updates, communications, training alignment, and adoption support.
- Collaborate with enterprise and functional teams to ensure R&D needs are represented in standardized global business processes and QMS documentation.
- Maintain awareness of relevant regulatory and industry trends affecting R&D quality processes and share implications with stakeholders; coordinate interpretation and actions through the Operational Controls Lead and appropriate governance bodies.
- Build and maintain an inventory of R&D stakeholders, including functional leads.
- Identify and engage primary, secondary, and informed stakeholders for each process, ensuring robust communication, strategic document management, training, and delivery planning.
- Collaborate with R&D teams to ensure processes are fit-for-purpose and support innovation, scientific rigor, compliance, and increased value of Quality.
Basic Requirements:
- 7+ years’ experience in the pharmaceutical industry in business, quality, or operational roles, with demonstrated understanding of research and development processes and/or clinical operations.
- Bachelor’s degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field.
Additional Skills/Preferences:
Proven ability to work in a matrixed organization leading diverse teams and influencing areas not under direct control, especially in R&D environments.
Experience supporting cross-functional or multi-site process improvement initiatives in R&D.
Strong strategic thinking capability with a focus on executing strategic decisions while balancing conflicting priorities in research and development.
Ability to drive process improvements and strategic decisions by analyzing and interpreting complex R&D data.
Demonstrated change agility in anticipating and leading others through change and ambiguity in scientific and regulatory contexts.
Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate at all levels through various formats.
Expertise in developing scalable and standardized processes across global R&D operations to improve efficiency and reduce complexity.
Demonstrated ability to influence and partner effectively with R&D functional leads and process owners.
Demonstrated ability to balance speed, quality, and risk and to recommend actions that deliver value-added results.
Strong capabilities in establishing governance structures and proactively addressing quality and regulatory risks in research and development.
Demonstrated ability to lead through influence in a matrixed environment.
Expertise in navigating and ensuring adherence to global regulatory standards and frameworks relevant to R&D.
Available to travel (domestic and international) when required (ca. 10%).
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
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 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).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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