Job Details

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 work worldwide to discover and deliver life-changing medicines, improve disease management, and contribute to our communities through philanthropy and volunteerism. We prioritize our efforts and people, seeking individuals committed to bettering lives globally.

About the job

We are seeking a Senior Director, Global Process Owner for Deviations & CAPAs to lead the global quality system for Deviations and CAPAs within the Global Quality System team. This role involves establishing and maintaining standards, practices, and IT systems, leading a community of practice, and managing key projects to ensure compliance and continuous improvement across Lilly's operations.

Responsibilities

1. Establish and maintain global quality systems for Deviations & CAPAs to ensure standardization.
2. Own and design global standards, processes, training, and tools in compliance with regulatory and industry expectations.
3. Lead implementation initiatives, foster compliance, and monitor performance signals for continuous improvement.
4. Ensure IT applications and analytical tools support business needs and reporting accuracy.
5. Define and monitor global metrics for performance and effectiveness.
6. Develop and mentor a community of SMEs, fostering collaboration and process knowledge.
7. Collaborate on standardized global processes across enterprise teams.
8. Ensure inspection readiness and interact with Health Authorities during inspections, drafting responses as needed.
9. Engage with external organizations to stay abreast of policy changes and advocate for quality policies.

Basic Requirements

• 10+ years' experience in pharmaceutical industry roles in research, development, or manufacturing.
• Bachelor's degree in Natural Science, Engineering, Pharmacy, or related Life Science field.

Additional Skills/Preferences

• Proven leadership in matrixed organizations and global initiatives.
• Strong strategic, analytical, and change management skills.
• Excellent communication and leadership capabilities, with experience in regulatory standards and team management.
• Willingness to travel (~10%) and fluency in English; additional languages preferred.
• Role location can be US or Europe, with remote work considered.

Lilly values diversity and accommodations for individuals with disabilities. For assistance, please complete the Workplace Accommodation Form.