Sr. Principal, Global Quality Systems Business Partner

Eli Lilly and Company • Limerick, IN

12d

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 corresponding processes, while serving as a primary quality liaison offering hands-on quality leadership and strategic guidance. The role helps embed product quality, regulatory compliance, and continuous improvement into day-to-day business decisions. It supports global and functional partners in developing, executing, monitoring, and improving global standards and procedures to ensure processes are standardized, simple, and compliant.

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

The anticipated wage is $101,250–$171,600. Full-time equivalent employees are also eligible for a company bonus, depending in part on company and individual performance. Lilly offers eligible employees a comprehensive benefits program. Travel is 0–10%, including the possibility of domestic and international site visits, 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 is preferred, such as chemistry, microbiology, pharmacy, or engineering.
• 10 or more years of experience in a pharmaceutical, biotech, or medical device setting.
• Strong knowledge and technical expertise in cGxPs and industry guidance concerning 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 during ambiguity.
• 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 carry out tasks independently and work effectively in a team environment.
• Strong project management and organizational skills.
• Demonstrated ability to interpret and apply standards to different situations, understand partner and leadership needs, solve problems, and collaborate and communicate effectively.
• Ability to write technical documents, develop business presentations, and communicate concepts to a wide range of personnel, including senior leadership.
• Authorization to work in the United States on a full-time basis; the employer will not sponsor work authorization or visas for this role.

Nice To Haves

• Bachelor’s degree in a scientific field, such as chemistry, microbiology, pharmacy, or engineering.
• Experience leading a major multi-site or global functions improvement initiative.
• Experience designing or executing a scalable, standardized pharmaceutical QMS across diverse pharmaceutical operations and requirements, such as dry, parenteral, API, device, development, or ATMP operations.
• Experience with quality systems, governance, metrics, and continuous improvement methodologies.

Responsibilities

• Provide quality oversight and partner with assigned pillar GPOs and Level 2 process associates and leaders to align quality strategy with operational and business goals.
• Support the design and continuous improvement of Global Quality Standards, Global Procedures, related documents, and training.
• Provide guidance, coaching, and interpretation of quality expectations to GPOs, global and functional associates, and leaders on 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 documentation.
• Analyze evolving regulatory and industry expectations and support education, training, implementation tools, and emerging technologies to promote simplicity, consistency, and compliance.
• Support monitoring of QMS health by analyzing KPIs, quality metrics, and other performance data; report trends and risks to leadership and support continuous improvement initiatives.
• Lead or support the assessment, development, and implementation of critical and complex global projects through cross-functional working groups.
• Engage with regulatory or industry forums and share expertise 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 QMS misalignment and potential risks; propose solutions, support risk assessments and quality risk management activities, and influence global initiatives and control strategies.

Benefits

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

What This Job Offers

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