Sr. Principal, Global Quality Systems Business Partner

Lilly • Kinsale, Indiana

7d • $101,250 - $171,600

About The Position

The Sr. Principal, Global Quality Systems Business Partner is a technical leadership position providing independent oversight of Global Quality Management System (QMS) pillars and their processes, while serving as a primary quality liaison who provides hands-on quality leadership and strategic guidance. The role ensures product quality, regulatory compliance, and continuous improvement are incorporated into daily business decisions. It supports QMS pillar processes and global and functional partners in developing, executing, monitoring, and continually improving global standards and procedures to keep processes standardized, simple, and compliant.

The position consults with Global Process Owners (GPOs), global and functional partners, and network and site leadership on quality assurance matters. It proactively supports compliance with regulatory expectations and scientific principles, aligning quality strategy with operational and business goals. The role also engages with external forums to identify industry trends and support Lilly’s external influence initiatives, influences organizational leaders and partners, and mentors colleagues in quality principles and culture.

The anticipated salary range is $101,250–$171,600. Full-time employees are eligible for a company bonus, depending in part on company and individual performance. Eligible employees may participate in a company-sponsored 401(k) and pension and may receive vacation, medical, dental, vision, prescription drug, flexible spending account, life insurance, time-off and leave, and well-being benefits. Travel is 0–10%, including possible domestic and international site visits and attendance at training courses and conferences. Applicants must be authorized to work in the United States on a full-time basis; Lilly will not sponsor work authorization or visas for this role.

Requirements

• Bachelor’s degree; a scientific field such as Chemistry, Microbiology, Pharmacy, or Engineering is preferred.
• 10+ years of experience in a pharmaceutical, biotech, or medical device setting.
• Strong knowledge and technical expertise in cGxPs and industry guidance for quality management, computer systems, third-party quality management, exception handling, document and training management, incident handling, and marketing affiliate operations, including relevant cGMP and FDA requirements.
• Demonstrated global cross-functional technical leadership and ability to influence strategy and stakeholders without direct authority, including in ambiguous situations.
• Strategic thinking and leadership capability to make and act on decisions while balancing speed, quality, risk, business results, and conflicting priorities.
• Ability to plan and complete tasks independently while also working effectively in a team environment.
• Strong project management and organizational skills.
• Ability to interpret and apply standards to different situations, understand partner and leadership needs, and use sound problem-solving skills, communication, and collaboration.
• Ability to write technical documents, develop business presentations, and communicate concepts effectively to a wide range of personnel, including senior leadership.
• Applicants must be authorized to work in the United States on a full-time basis; Lilly will not sponsor work authorization or visas for this role.

Nice To Haves

• Experience leading a major multi-site or global-function improvement initiative.
• Experience designing or executing a scalable, standardized pharmaceutical QMS across diverse operations and requirements, such as dry, parenteral, API, device, development, or ATMP operations.
• Experience with quality systems, governance, metrics, and continuous improvement methodologies.
• Previous experience in a scientific field such as Chemistry, Microbiology, Pharmacy, or Engineering.

Responsibilities

• Provide quality oversight and partner with assigned pillar GPOs and Level 2 process global and functional associates and leaders to align quality strategy with operational and business goals, and support the design and continuous improvement of Global Quality Standards, Global Procedures, related documents, and training.
• Guide, coach, and interpret quality expectations for GPOs, global and functional associates, and leaders to support robust compliance in managing technical, quality, and compliance issues.
• Author, review, or approve GxP documents—including strategies, standards, procedures, training, protocols, reports, qualifications, specifications, deviations, change controls, and CAPA—to ensure quality attributes and compliance through closure.
• Analyze evolving regulatory and industry expectations, and support education, training, implementation tools, and emerging technologies that promote simplicity and consistency and ensure compliance with cGMP, FDA, and other applicable global regulatory requirements.
• Support QMS health monitoring by analyzing KPIs, quality metrics, and performance data; report trends and risks to leadership; and support continuous improvement initiatives.
• Lead or support assessments, development, and implementation of critical and complex global projects through cross-functional working groups to achieve significant quality improvements or technical agenda objectives.
• Engage with regulatory and industry forums and share expertise inside and outside Lilly through technical publications and presentations.
• Support internal and external audits and regulatory inspections, including preparation of responses as needed.
• Coach and mentor peers, junior associates, and leaders on the QMS, quality principles, quality culture, and regulatory expectations.
• Identify and propose solutions to QMS misalignment and potential risks, influence global initiative direction, and support risk assessments and quality risk management activities across the business unit.

Benefits

• Company bonus, depending in part on company and individual performance
• Company-sponsored 401(k) participation
• Pension
• Vacation benefits
• Medical, dental, vision, and prescription drug benefits
• 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 an employee assistance program, fitness benefits, and employee clubs and activities

What This Job Offers

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