Sr. Principal, Global Quality Systems Business Partner

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

The Sr. Principal, Global Quality Systems Business Partner is a technical leadership position providing independent oversight of the Global Quality Management System (QMS) Pillars and their corresponding processes (GPOs and global/functional partners), while also acting as the primary quality liaison providing hands-on quality leadership and strategic guidance. This role ensures product quality, regulatory compliance, and continuous improvement are embedded in day-to-day business decisions, while supporting a broad range of QMS pillar process topics and global/functional partners in the development, execution, monitoring of process health, and continuous improvement of the global standards and procedures, ensuring standardized, simple, and compliant processes.

This role consults GPOs, global/functional partners, and network/site leadership on quality assurance matters and proactively assures compliance with regulatory expectations and scientific principles to align quality strategy with operational and business goals. The role engages externally for identifying industry trends and supporting Lilly's external influence initiatives, and engages and influences leadership, global/functional partners, and mentors colleagues in quality principles and culture to develop capabilities within the organization.

Key Objectives/Deliverables:

- Provide quality oversight and partner with assigned pillar GPOs and Level 2 (L2) process global/functional associates and leadership to align quality strategy with operational and business goals, supporting the design and continuous improvement of Global Quality Standards, Global Procedures, and related documents and training.

- Provide guidance, coaching, and interpretation of quality expectations to GPOs, global/functional associates, and leadership to ensure robust compliance in managing key technical, quality, and compliance issues.

- Effectively author, review, or approve GxP documents to ensure quality attributes are met and compliant with quality standards through closure (e.g., strategies, standards, procedures, training, protocols, reports, qualifications, specifications, deviations, change controls, CAPA).

- Provide analysis of evolving regulatory and industry expectations, education, training, implementation tools, and emerging technologies to promote simplicity and consistency, ensuring compliance with cGMP, FDA, and other applicable global regulatory requirements.

- Support the monitoring of the health of the QMS through analysis of KPIs, quality metrics, and other performance data, reporting trends and risks to leadership, and support the identification and implementation of continuous improvement initiatives.

- Lead and/or support the assessment, development, and implementation of critical and complex global projects within cross-functional working groups in support of continual and significant quality improvements or technical agenda objectives.

- Engage externally with regulatory or industry forums to share expertise within and outside Lilly through technical publications and presentations
- Support internal/external audits and regulatory inspections, including response preparation as needed.

- Coach and mentor colleagues, including peers, junior associates, and leadership, on key aspects of the QMS, quality principles, quality culture, and regulatory expectations.

- Identify and propose solutions to existing misalignment or potential risks related to the QMS and control strategies to mitigate risk and influence direction on global initiatives, including supporting risk assessments and quality risk management activities across the business unit.

Basic Qualifications

·       Bachelor's Degree - Preferred in a Scientific Field (e.g., Chemistry, Microbiology, Pharmacy, Engineering)

·       10+ years in pharmaceutical, biotech, or medical device setting

·       Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Skills:

- 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 including cGMP and FDA regulatory requirements relevant to assigned scope.

- Demonstrated cross-functional technical leadership at the global level to influence and contribute to strategy, including the ability to work cross-functionally and influence stakeholders without direct authority during times of ambiguity.

- Strong strategic thinking, leadership capability to make and act on decisions while balancing speed, quality, and risk to deliver value-added business results while balancing conflicting priorities.

- Proficiency in planning and the ability to carry out tasks with a high degree of independence as well as being able to work in a team environment.

- Experience leading a major multi-site or global functions improvement initiative.

- Strong project management and organizational skills.

- Demonstrated ability and agility to interpret and apply standards to different situations by understanding partner/leadership needs and applying good problem-solving skills, with strong communication and collaboration abilities.

- Demonstrated ability to write technical documents, develop business presentations, and effectively communicate concepts to a wide range of personnel, including senior leadership.
- Previous experience with designing or executing a scalable/standardized pharmaceutical quality management system among a diverse range of pharmaceutical operations and requirements (e.g., Dry, Parenteral, API, Device, Development, ATMPs), and/or experience with quality systems, governance, metrics, and continuous improvement methodologies.

Additional Information:

·       Travel - 0-10% Ability to attend training courses, conferences, and both domestic and international for site visits.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is
$101,250 - $171,600

###

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

#WeAreLilly