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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 Associate Vice President for Global Quality Systems plays a pivotal role in establishing and maintaining Lilly's quality management system (QMS) at the enterprise level. This includes overseeing the document hierarchy, which encompasses global standards, procedures, enabling technology and required tools. The role involves governance of the QMS global process owner framework, business processes, and implementation tools to ensure a robust and compliant quality system.

A key responsibility of the Associate Vice President is to proactively ensure that Lilly’s quality management system adheres to regulatory standards established by global health authorities, industry trends, and scientific principles. This role is crucial in conducting the Integrated Management Review, which monitors and ensures the health and effectiveness of the enterprise quality management system. In addition, for ensuring findings and recommendations are reported to senior leaders to support strategic decision-making.

Collaboration is a cornerstone of this role, as the Associate Vice President works closely with Lilly Research Laboratories, alliance partners, manufacturing sites, affiliates, and other key stakeholders to design and implement an integrated quality system. Leading and managing key global projects linked to the Quality Management System, the Associate Vice President effectively prioritizes initiatives to deliver impactful results.

The Associate Vice President supports global manufacturing sites in executing the Lilly quality management system, providing administrative supervision to QMS global process owners, advisors, and support staff. This supervision ensures the continuous improvement and maintenance of the quality system, including data management.

The Associate Vice President also collaborates with global manufacturing operations to ensure that quality systems are consistently applied and maintained across all production sites, fostering a culture of continuous improvement and compliance.

In addition, the Associate Vice President plays a critical role in integrating quality systems across research and development and global manufacturing operations. This involves working with R&D teams to ensure that quality standards are embedded in the development of new products and processes.

The Associate Vice President is instrumental in driving a transformative agenda through continuous improvements and cross-functional collaboration. By prioritizing initiatives that deliver results and fostering a culture of innovation, the Associate Vice President ensures that Lilly remains at the forefront of quality management in the industry.

Key Objectives/Deliverables

The development, maintenance, and enhancement of global quality systems that regulate GxP activities in manufacturing operations, research and development, sales, and marketing worldwide is essential. This encompasses the global application of quality risk management principles, proactive development and upkeep of quality standards, and the adoption of innovative approaches to ensure reliable performance at scale.

Deliverables

Enterprise Quality Management System** **: Provide leadership and continuous improvement of processes comprising the enterprise QMS.

Integrated Management Review** **: Conduct the Integrated Management Review to monitor and confirm the health of Lilly quality management system.

Strategic Reporting** **: Report findings and recommendations to senior management to support strategic decision-making.​

Cross-Functional Collaboration** **: Collaborate across business functions to gather and analyze relevant data to assess quality performance at the enterprise level.

Key Performance Indicators** **: Identify key performance indicators to monitor compliance with the global QMS. Anticipating and ensuring timely response to compliance signals.

Effectiveness and Compliance** **: Ensure that the quality system remains effective and compliant with industry standards.

Governance of Global Process Owner Framework** **: Provide leadership and continuous improvement of the global processes that comprise the enterprise-wide Quality Management System.

Quality Oversight of Centrally Led Processes and Site Support** **: Provide quality oversight and support for centrally governed quality processes. Provide technical consulting on quality issues to quality units and functions worldwide regarding the interpretation and implementation of global quality systems.

Innovation** **: Foster a culture of innovation by identifying and implementing cutting-edge quality management practices and technology.

Continuous Improvement** **: Encourage continuous improvement and creative problem-solving to enhance the effectiveness and efficiency of the quality management system. Lead and/or support the assessment, development, and implementation of critical global projects in support of continual improvements.

Industry Trends and Regulatory Awareness** **: Maintain current awareness of global industry trends and regulatory agency interpretation of Current Good Practice (CGxP) requirements. Assess and influence the internal and external environment with respect to topics pertaining to GxP.

Sound Business Practices** **: Develop and meeting budgets. Establish, prioritize, and evaluate attainment of goals and objectives that are linked Lilly’s quality strategic plans, including innovations such as new modalities.

Strong Leadership** **: Successfully lead a global team with diverse backgrounds and technical expertise.

Basic Qualifications:

Education: BS, MS, or PhD in pharmacy, physical or biological sciences, engineering, or other technical area of study.

Experience:

Minimum of 20 years of direct experience in pharmaceutical operations in areas subject to GMP, GCP, and/or GLP.

Demonstrated leadership skills in successfully managing cross-functional and geographically dispersed global teams.

Proven ability to lead enterprise-level change and transformation initiatives, including digital quality systems and innovation adoption.

Demonstrated ability to successfully collaborate and build strong relationships across departments and influence stakeholders to achieve common goals.

Strong knowledge of GxPs, quality management systems, and quality risk management.

Experience interacting with global health authorities and leading audit/inspection readiness activities.

Proficient in using digital tools and analytics to monitor QMS performance and inform decision-making.

Demonstrated ability to manage budgets, allocate resources, and deliver strategic priorities across a matrixed organization.

Additional Skills/ Preferences** **:

Visionary Thinking** **: The ability to set a clear vision for the quality management system and inspire others to achieve it.

Strategic Decision-Making** **: Making informed decisions that align with the company's strategic goals and regulatory requirements.

Effective Communication** **: Clearly articulating expectations, goals, and feedback to team members and stakeholders.

Adaptability and Resilience** **: Navigating complex challenges and adapting to changing industry trends and regulatory landscapes.

Commitment to Excellence** **: Demonstrating a relentless pursuit of quality and continuous improvement in all aspects of the role.

Empowerment and Development** **: Encouraging and developing team members to reach their full potential and contribute to the organization's success.

Additional Information:

Visits to research & development, manufacturing, affiliate sites, and external meetings and conferences.

Availability to travel (domestic and internationally).

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

$234,000 - $343,200

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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