Associate Vice President of QC Global Operations

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 & Role Overview:
Eli Lilly and Company is dedicated to bringing innovation to patients and is growing its manufacturing operations significantly to meet the demand for our medicines.  As a result, our Global Quality Analytical Sciences & QC Operations organization responsible for delivering the commercialization and lifecycle of analytical methods as well as innovative standardized tools to the QC laboratories globally is also growing.  The Associate VP for the Global QC Operations team provides leadership for the organization that supports the Global QC Laboratories by providing the innovative technologies and informatics tools, standardized business and GMP processes, QC Operational Excellence principles and functional standards that facilitate the site operations.  This team defines the vision and is responsible to deliver the tools in extensive collaboration with the QC laboratories globally that will enable a paperless, best in class global QC operation across the expanding Lilly manufacturing footprint.

Responsibilities:

Functional:

• Provide Leadership for the design, implementation, and maintenance of the best in class digitally enabled QC laboratory
• Introduce latest capabilities and technological advancements to transform lab operations
• Ensure implementation & optimization of standards, methods, procedures, and sampling for testing and evaluating the precision, accuracy, and reliability of the product
• Collaborate with Drug Product and Drug Substance counterparts to ensure adherence standards and guidelines established by Global QC Operations organization.
• Collaborate with site QC labs and foster relationship to ensure they have end to end visibility of key initiatives and strategies and are implementing the standardized processes to enable paperless, best in class QC laboratories.
• Define the strategy for establishment and oversight of release/stability testing CoE’s as well ensuring timely and efficient release of products as appropriate
• Lead the QC Operations team including the global QC Op Ex team, the QC Informatics organization, and the QC GMP Business Process standardization teams.   Identify and manage continuous improvement projects with the objective of achieving quality, reliability, and cost improvements. 
• Provide leadership for the deployment of the tools to new and existing laboratories, ensure reliable operations and excellence in execution.
• Engage in the external environment as it relates QC Operational Excellence and QC lab innovation.

Leadership:

• Provide strategic direction and leadership to the team.
• Ensure safe operations for the organization.
• Cultivate a culture of continuous improvement and innovation.
• Foster cross-functional collaboration and synergy, ensuring all units are aligned in their objectives and operations.
• Develop and mentor team members and QC leaders, promoting personal and professional growth
• Lead the QC Operations team from a budget, organizational, lab strategy, and team development perspective.
• Establish a service-oriented organization supporting global pipeline products as well as capacity expansion.
• Interact frequently with all levels of internal management across functions and business units
• Promote innovation and digitalization, fostering initiatives that reduce environmental impact
• Cascade and spread out the vision and values of the organization within the QC laboratories

Basic Requirements: 

• Bachelor's degree in a scientific field related to the laboratory, such as Chemistry, Biological Sciences, Engineering or related a Life Sciences field.
• A minimum of 15 years of experience in the pharmaceutical industry and at least 5 years in a leadership role.
• Extensive knowledge of GMP and other pharmaceutical industry regulations and standards.
• Proven experience in leading and managing QC Operations and laboratory functions.
• Strong knowledge of Operational Excellence and application of lean principles
• In-depth knowledge of the regulatory environment for the manufacture of pharmaceutical products.
• Strong knowledge of FDA, EMA, and ICH regulations and USP, EP, JP, and CHP requirements.
• Proven ability to drive innovation and change within an organization.

Additional Skills/Preferences:

• Strong leadership and team management skills.
• Excellent problem-solving abilities and a strategic mindset.
• Strong knowledge of AI and informatics within a laboratory setting.
• Exceptional communication and interpersonal skills.
• Advanced skills with key applications for Program Management (i.e., PowerPoint, Excel, MS Project, Visio, etc.)
• Has worked in international and multifunctional teams
• Communicate effectively with all levels of management
• Demonstrate a breadth of diverse leadership experiences and capabilities instrumental in shaping the future of our laboratories and QC operations
• A visionary leader and change agent who can drive innovation and operational excellence while maintaining the highest standards of quality and compliance

Additional Information:

• This position requires travel to domestic and international destinations.
• This position requires working in manufacturing environments where there may be specific gowning or dress code requirements.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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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