Sr Principal Global Quality Systems Lead

Initial Therapeutics, Inc.; Indianapolis (IN); Hybrid; USD 65,000 - 169,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Pension

Job summary

Lilly is seeking a Sr Principal (R4+) Global Quality Systems Lead to oversee and align QMS processes across the organization, supporting commercial and Clinical Supply functions. The role emphasizes governance, strategy, and continuous quality improvements within the Global Process Ownership framework.

Based in Indianapolis with some travel and a hybrid work arrangement, the position requires strong cGMP knowledge and collaboration with multiple functions to ensure compliance and quality across

Qualifications

• 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.
• 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.
• Previous experience with Quality Risk Management and global quality system governance.

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.

Skills

cGMP experience

Quality governance

GxP understanding

Lean/CI

Education

Bachelor's degree in science/engineering

Job description

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.

Job Position Overview:

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.

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.

Basic Qualifications:

• Education Level: Bachelor's degree or equivalent in a scientific field, engineering, or a related discipline.
• Experience: 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.
• Certifications: N/A.
• Licenses: N/A.
• Language Requirements: Fluent in English; additional languages are preferred.
• Required Skills Testing: N/A.

Additional Skills/ Preferences:

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.

Additional Information:

Requires visits to manufacturing sites and the ability to attend external training courses, conferences, or association meetings.

• Position Location: Hybrid position based at a Lilly facility in Indianapolis, Indiana; Fegersheim, France, Alcobendas, Spain with flexibility for some remote work.
• Travel Percentage (%): Approximately 10%.
• Shift Information: N/A.

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

$65,250 - $169,400

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.

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