Senior Director, Global Process Owner - Deviation & CAPA

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.

About the job

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.

Responsibilities

The Senior Director, Global Process Owner for Deviations & CAPAs, as a leader within the Global Quality System team, will establish and maintain the global quality system for Deviations and CAPAs. They will provide strategic oversight and expertise for the global Deviation and CAPA processes, including Global Quality System standards, practices, business processes, implementation tools and associated IT systems. Additionally, the Global Process Owner will lead the Deviation and CAPA 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 Lilly manufacturing facilities, external supplier organization, marketing affiliate quality operations, research and development 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.

Key Objectives/Deliverables

The Senior Director, Global Process Owner for Deviations & CAPAs is responsible to:

• Establish and maintain the global quality systems for Deviations & CAPAs to drive standardization globally.
• Own the Global Standard, Processes, Practices, Trainings, and implementation tools and ensure they are designed according to regulatory, industry and company expectations.
• Provide governance, lead the implementations of improvement initiatives and foster a robust compliance mindset.
• Ensure processes are executed consistently across the organization and monitor signals to drive continuous improvement.
• Act as the leader and SME to ensure supporting IT applications and analytical tools are configured and maintained to support the business needs and facilitates accurate reporting and analytics.
• Define a common set of global effectiveness and efficiency metrics to drive end-to-end performance.
• Monitor performance metrics, report and provide insights to inform decision making to drive further improvements.
• Develop, lead, mentor and maintain a community of cross-functional SMEs to collaborate on proposed improvements and deepen the knowledge of the associated processes & tools.
• Actively collaborate with enterprise-wide teams on standardized global business processes.
• As the subject matter expert, ensure inspection readiness, directly interact with Health Authorities during inspections and draft responses to observations as needed.
• Actively engage in external organizations and industry organizations to monitor policy changes for regulatory / external environments and advocate / influence quality related policies and regulatory requirements related to Deviations & CAPAs.

Basic Requirements:

• 10+ years’ experience in the pharmaceutical industry in business or quality operational roles across Research and Development or commercial manufacturing.
• Bachelor’s degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field.

Additional Skills/Preferences:

• 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 strategic thinking capability with a focus on the ability to execute strategic decisions while balancing conflicting priorities.
• Proficiency in addressing operational challenges through structured approaches and innovative 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 value-added 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 overseeing the Deviation program and upskilling teams to improve investigations, the effectiveness of CAPA’s and the writing of deviations.

Additional Information:

• Available to travel (domestic and international) when required (ca. 10%)
• Fluent in English, additional languages are also recommended.
• Role may be based at selected locations in US or Europe. Remote work may be considered.

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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