Sr. Director - Quality Transformation and Technology

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.

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Responsibilities:

The Senior Director of Quality Transformation and Technology is responsible for driving changes to the global quality compliance organization from a current state to a desired future state, with a focus on maintaining or improving quality excellence throughout the process. This role involves setting overall strategic direction for quality compliance, partnering with global cross-functional teams, and leading a team that has global impact.

The Senior Director of Quality Transformation and Technology is expected to influence Quality staff and multiple functional teams for the delivery of quality products, as well as monitoring quality performance indicators to drive continuous improvement of Quality operations.

The Senior Director of Quality Transformation and Technology partners with organizations globally to implement solutions to achieve quality operational excellence and drive a strong culture of Quality. The role also requires leading quality governance processes and overseeing strategic planning capacity planning for initiatives and or processes upholding Lilly Quality Management System.

The Senior Director of Quality Transformation and Technology is responsible for establishing, owning, and transforming processes that will support continuous quality improvement and drive quality compliance throughout Lilly’s GxP operations.  The role is responsible for developing the portfolio of improvement opportunities, prioritizing, and managing implementation of new technology and process changes.

The Senior Director of Quality Transformation and Technology reports to the Sr. Vice President, Global Quality Compliance.

Key Objectives/Deliverables:

The Senior Director, Quality Transformation and Technology is responsible for:

• Driving substantial changes to the organizational culture and achieve engagement of employees needed to meet Quality expectations.
• Propelling initiatives to improve performance, develop behavior focused on quality excellence and increase sustainability of quality operational excellence programs. 
• Fostering creative thought process to drive innovative approaches to keep a Quality mindset, anchored in monitoring leading indicators against long-term Quality objectives. 
• Overseeing capacity planning for capabilities required to drive strategies and initiatives impacting the Global Quality Compliance programs and in alignment with pipeline growth and commercial product expansion and preparing for future innovations.
• Leading data collection, analysis, decision making relevant for the development and approval of business plan and of capital investment to support Quality Compliance and Management Review Programs.
• Play a leading role during Quality governance processes to support the enterprise.
• Preparing materials for a broad spectrum of internal and external stakeholders to enable risk-based decision making across GxP Quality domains.
• Leading the assessment, development, and implementation of cross-functional transformational projects in support of global quality compliance continual improvement.
• Overseeing delivery of prioritized projects, tracking key performance indicators, and reporting progress on quality operational excellence.
• Identifying quality digital innovations to improve quality performance and ensuring on time delivery of compliant technology solutions.
• Facilitating rapid adoption of compliant approaches to support innovations from the enterprise ensuring quality compliance (e.g., new modalities).
• Leading the establishment and maintenance of robust quality systems, including risk management, compliance, and continuous improvement processes.
• Leading and mentoring quality professionals, fostering a culture of quality and continuous improvement.
• Designing and managing the knowledge management program across the global quality organization.
• Developing and managing a team responsible for quality improvements and supporting Global Quality Compliance operation.
• Working across organizations and functions to establish effective partnerships and processes.

Basic Qualifications:

• BS, MS, or PhD in a field of science, engineering, pharmacy, or medicine.  (MBA preferred)
• 15+ years of experience in the pharmaceutical industry, in areas of CGxP’s, across research and development, commercial manufacturing, pharmacovigilance, information quality.

Additional Preferences:

• Demonstrated strategic thinking, learning agility, analytical skill, and complex analysis.
• Experience in leading strategic and business planning activities.
• Experience across manufacturing functions and technologies preferred.
• Demonstrated experience in IT solution delivery and support.
• Demonstrated leadership acumen, including project leadership.
• Demonstrated ability to build and maintain collaborative relationships with external/internal stakeholders; navigate complex issues and find common ground with multiple constituencies with differing, and often opposing, perspectives.
• Strong collaboration, negotiation, problem solving, and interpersonal skills. Proven record of finding solutions.
• Demonstrated ability to communicate with and influence across a broad range of levels, functions, and stakeholders across the enterprise, inclusive of writing technical documents, develop business executive level materials.
• Good analytical skills: black belt certification preferred

Additional Information:

• Ability to travel (domestic and internationally) <20%

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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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