Sr. Manager - QA Assurance

Position Overview

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.

Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. We are seeking an experienced Quality Assurance Manager to support our growth in the Research Triangle Park state-of-the-art facility production site. This is an outstanding opportunity to deliver on new manufacturing investments and pioneering technologies.

The Senior Manager, Quality Assurance is responsible for providing leadership and technical oversight for the formulation, filling, and visual inspection areas to ensure compliance with regulatory requirements, corporate standards, and industry best practices.

This role combines people management with technical quality expertise, driving team structuring, collaborator development, continuous improvement of regulated processes, documentation, and operational readiness.

The Senior Manager will help build a strong quality culture, lead inspection readiness, and provide ongoing operational support.

• Build and manage a functional QA organization that supports operational excellence, lean practices, and shopfloor presence.
• Lead, mentor, and coach QA floor teams, fostering a culture of safety, quality, compliance, and continuous improvement.
• Establish and monitor performance objectives, providing feedback and coaching to drive team development.
• Identify business and quality risks, escalating appropriately and in a timely manner.

• Provide continuous quality improvement oversight to regulated processes, practices, and documentation.
• Review and approve GMP documentation, including procedures, deviations, technical reports, and change controls to ensure compliance with Lilly Global Quality Standards and regulatory requirements.
• Network with global and parenteral sites to share best practices, improve processes and resolve product-related issues.
• Work cross-functionally with process teams for metrics reviews, operational support, and deviation management.
• Provide guidance and share technical knowledge in operational areas to ensure robust Quality Systems and GMP compliance.
• Participate in inspections from regulatory agencies and corporate audits, and manage responses to findings.
• Ensure compliance with corporate, local, and regulatory agency policies, procedures, and guidelines.
• Provide QA oversight of formulation, filling operations using isolator technology, and visual inspection processes.
• Lead or participate in non-routine investigations, root cause analysis, and corrective/preventive actions.

• Bachelor’s or Master’s degree in Engineering, Life Sciences, or related field.
• 5+ years of experience in Quality Assurance, with at least 3 years in a leadership role.
• Demonstrated strong experience and proficiency with pharmaceutical manufacturing and working knowledge of Quality Management Systems and applicable regulatory requirements.
• Demonstrated attention to detail and ability to maintain quality systems.
• Previous experience leading or working effectively with a cross-functional group.
• Demonstrated excellent interpersonal, written and oral communication skills.
• Demonstrated strong technical aptitude and ability to train and mentor others.
• Demonstrated decision making and problem-solving skills.
• Demonstrated ability to organize and prioritize multiple tasks.

• Previous experience with highly automated parenteral manufacturing processes including isolators, automated inspection, etc.
• Previous experience with Manufacturing Execution Systems and electronic batch…