Senior Director, Global Process Owner - Global Quality System

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Senior Director, Global Process Owner - Global Quality System

As part of the Global Quality System’s team, Eli Lilly is hiring Senior Director Global Process Owners within the following workstreams:

• Deviation & CAPA
• Document Management
• Quality Risk Management
• Quality Governance

These senior leaders will establish and maintain the global quality system for their workstream. They will provide strategic oversight and expertise for global processes, including Global Quality System standards, practices, business processes, implementation tools and associated IT systems. Additionally, the Global Process Owners will lead their workstream Community of Practice, including Global Process Leads and Area Process Owners. They will lead key global projects and priorities within the Quality System.

The Global Process Owner will consult with users from Research & Development, Commercial Manufacturing, External Supplier, Regulatory and other functions to educate on the quality system and proactively ensure compliance of Lilly’s Quality Systems with various country agency standards, industry trends and scientific principles.

What you Should Bring

• Proven ability to work in a matrixed organization leading diverse teams and influencing areas not under direct control.
• Experience leading a major multi-site or global functions improvement initiative.
• Strong capability to implement strategic decisions while balancing conflicting priorities.
• Proficiency in addressing operational challenges through structured approaches and novel solutions.
• Ability to drive process improvements and strategic decisions by analyzing and interpreting complex data.
• Demonstrated change agility in anticipating and leading others through change and ambiguity.
• Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate at all levels through various formats.
• Expertise in developing scalable and standardized processes across global operations to improve efficiency and reduce complexity.
• Demonstrated influential leadership expertise and experience engaging with senior-level functional leads.
• Strong leadership capability to make and act on decisions while balancing speed, quality, and risk to deliver impactful business results.
• Strong capabilities in establishing governance structures and proactively addressing quality and regulatory risks.
• Demonstrated people management experience.
• Expertise in navigating and ensuring adherence to global regulatory standards and frameworks.
• Prior experience owning the process or leading the team supporting the creation, revision, obsoleting and archiving of QMS related documents.
• OR
• Prior experience overseeing the Deviation program and upskilling teams to improve investigations, the effectiveness of CAPA’s and the writing of deviations.
• OR
• Prior experience working in at least two of Clinical Operations / Development, Pharmacovigilance, Product Research & Development or Commercial Manufacturing preferred.
• OR
• Prior experience leading quality governance processes, performing trending and analytics to drive improvements.

Basic Requirements

• Significant experience in the pharmaceutical industry in GxP roles.
• Bachelor’s degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field.
• Fluent in English, additional languages are also recommended.

These positions may require travel to domestic and international destinations (ca. 10%)

These are onsite positions and can be based in US or Europe.

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 Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.

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

$151,500 - $222,200

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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