Sr Principal Global Quality Systems Lead

Lilly • Concord, NC

7d • $65,250 - $169,400 • Hybrid

About The Position

The Sr Principal (R4+) – Global Quality Systems Lead will provide oversight and support of QMS processes under Global Process Ownership for non-Quality owned processes. The role additionally ensures alignment with the greater Quality Management System (QMS) in terms of strategy, infrastructure, and business tools. This role is essential in maintaining the integrity and evolution of the process framework by developing connections, standards, and governance to support commercial and Clinical Supply functions. The role supports the QMS Pillar leads for the health, management, and reporting across the Operational Controls pillar of the QMS framework. Additionally, the GQS Lead will support QMS excellence by supporting the aligning of processes with business priorities, ensuring compliance, and driving quality improvements.

Requirements

• Bachelor's degree or equivalent in a scientific field, engineering, or a related discipline.
• Minimum of 7 years of direct cGMP experience, with strong knowledge of cGMP requirements and quality systems.
• Demonstrated experience in at least one relevant area or modality, such as Quality Control laboratories, cell and gene therapy, or parenteral manufacturing.
• Fluent in English; additional languages are preferred.

Nice To Haves

• Previous experience with Quality Risk Management and global quality system governance.
• Previous experience with process and equipment validation, cleaning and sterilization, GMP utilities, sterility assurance, or bioburden controls.
• Detailed knowledge of U.S. and European GMPs, ICH, PIC/S, and WHO expectations.
• Formal training in Lean, continuous improvement methodologies, or Quality Risk Management.
• Proven ability to interpret standards, understand customer needs, solve complex problems, and apply requirements across different situations.
• Proven ability to work independently and collaboratively, communicate constructive feedback, and develop and deliver effective presentations to varied audiences.
• Continuing education, a master's degree or higher in a science-related field, or previous facility or area start-up experience, including equipment and process validation support.

Responsibilities

• Provide oversight and consulting support to Global Process Owners, Communities of Practice, Area Process Owners, and network areas for the interpretation, implementation, review, and approval of global quality system processes and documents.
• Lead and continuously improve governance, management review, process monitoring, and prioritization across the Operational Controls pillar to support timely decisions, consistent execution, and QMS health.
• Assess, develop, and implement global quality system improvements, including standards, practices, training, implementation tools, effectiveness measures, and performance insights aligned with regulatory, industry, and company expectations.
• Partner across manufacturing, external supplier organizations, marketing affiliate quality operations, research and development, Clinical Supply, and other enterprise functions to manage process risks, strengthen capability, and enable standardized global business processes.
• Monitor regulatory and industry developments, support inspection readiness, and engage with external organizations to help maintain compliance and influence quality-related policies and requirements.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Principal