Senior Principal, Global Quality Systems Business Partner

Eli Lilly and Company

. Provide independent oversight of Global Quality Management System pillars and corresponding processes .

Posted 10/15/2026full-timeIndianapolis • United StatesSenior💰 $101,250 - $171,600 per yearWebsite

About the role

Key responsibilities & impact

Provide independent oversight of Global Quality Management System pillars and corresponding processes
Act as primary quality liaison, providing hands-on quality leadership and strategic guidance
Partner with pillar GPOs, Level 2 process associates, global/functional partners, and leadership
Support design and continuous improvement of Global Quality Standards, Global Procedures, related documents, and training
Provide guidance, coaching, and interpretation of quality expectations
Author, review, or approve GxP documents, including strategies, standards, procedures, training, protocols, reports, qualifications, specifications, deviations, change controls, and CAPA
Analyze evolving regulatory and industry expectations, education, training, implementation tools, and emerging technologies
Monitor QMS health using KPIs, quality metrics, and performance data; report trends and risks to leadership
Lead or support critical and complex global projects within cross-functional working groups
Engage with regulatory and industry forums through technical publications and presentations
Support internal and external audits and regulatory inspections, including response preparation
Coach and mentor peers, junior associates, and leadership on QMS, quality principles, quality culture, and regulatory expectations
Identify QMS misalignment and risks, propose solutions, support risk assessments and quality risk management activities
Attend training courses, conferences, and domestic and international site visits as needed, with 0–10% travel

Requirements

What you’ll need

Bachelor's Degree preferred in a scientific field such as Chemistry, Microbiology, Pharmacy, or Engineering
10+ years in a pharmaceutical, biotech, or medical device setting
Authorized to work in the United States on a full-time basis; Lilly will not provide work authorization or visa sponsorship
Strong knowledge and technical expertise in cGxPs and industry guidance in quality management, computer systems, third-party quality management, exception handling, document and training management, incident handling, and marketing affiliate operations
Demonstrated cross-functional technical leadership at the global level
Ability to influence stakeholders without direct authority during ambiguity
Strong strategic thinking and leadership capability
Ability to balance speed, quality, risk, and conflicting priorities
Proficiency in planning and carrying out tasks independently and in a team environment
Experience leading a major multi-site or global-functions improvement initiative
Strong project management and organizational skills
Ability to interpret and apply standards to different situations
Strong problem-solving, communication, and collaboration abilities
Ability to write technical documents and develop business presentations
Ability to communicate concepts to a wide range of personnel, including senior leadership
Experience designing or executing a scalable/standardized pharmaceutical quality management system across diverse pharmaceutical operations and requirements, and/or experience with quality systems, governance, metrics, and continuous improvement methodologies

Benefits

Comp & perks

Company bonus depending partly on company and individual performance
Company-sponsored 401(k)
Pension
Vacation benefits
Medical, dental, vision, and prescription drug benefits
Flexible benefits, including healthcare and/or dependent day care flexible spending accounts
Life insurance and death benefits
Time off and leave of absence benefits
Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities