Sr Principal Global Quality Systems Lead

Lilly; Kinsale; Hybrid; EUR 57,000 - 147,000; Full time

Benefits offered by this job

401(k) plan and pension

Job summary

Lilly seeks a seasoned Quality leader with a strong cGMP background to oversee global quality system processes and drive governance across the Operational Controls pillar. This hybrid role requires partnering with manufacturing, external suppliers, R&D, and other functions to implement improvements and ensure compliance.

Qualified candidates have 7+ years in cGMP, a scientific degree, and fluent English. Occasional site visits and international collaboration are expected.

Qualifications

• Bachelor's degree or equivalent in a scientific field, engineering, or related discipline.
• Minimum of 7 years of direct cGMP experience.
• Experience in at least one relevant area or modality (Quality Control labs, cell and gene therapy, or parenteral manufacturing).
• Fluent in English; additional languages preferred.

Responsibilities

• Provide oversight and consulting support to Global Process Owners, Communities of Practice, Area Process Owners, and network areas for interpretation, implementation, review, and approval of global quality system processes and documents.
• Lead and improve governance, management review, process monitoring, and prioritization across the Operational Controls pillar to support timely decisions and QMS health.
• Assess, develop, and implement global quality system improvements, including standards, practices, training, tools, and performance insights.
• Partner across manufacturing, external suppliers, marketing affiliate quality operations, R&D, Clinical Supply, and other functions to manage process risks and enable standardized global business processes.
• Monitor regulatory developments, support inspection readiness, and engage with external organizations to maintain compliance.

Skills

Quality governance

cGMP knowledge

Quality risk management

Regulatory compliance

Cross-functional collaboration

Education

Bachelor's degree in science/engineering

Job description

Job Position Overview:

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.

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; Concord, NC; Fegersheim, France; Alcobendas, Spain; Kinsale, Ireland 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 ( ) 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 ( ), 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).

• 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
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
• company bonus (depending, in part, on company and individual performance)

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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