Sr. Director -QMS Operational Controls

Job Details 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. Overview of Role: The Senior Director, QMS Operational Controls will provide central oversight of Operational Controls processes, ensuring alignment with the greater Quality Management System (QMS) in terms of strategy, infrastructure, and business tools. This role is essential in maintaining the integrity and evolution of the process framework by developing connections, standards, and governance to support commercial and Clinical Supply functions. The incumbent is accountable for health, management, and reporting across the Operational Controls pillar of the QMS framework. This leader will support excellence by aligning processes with business priorities, ensuring compliance, and driving quality improvements. High-Level Responsibilities:

• Lead Global Process Owners (GPOs) of non-Quality-owned processes to deliver process excellence in the Operational Controls Pillar of the QMS framework.
• Implement a structured governance and monitoring model to deliver excellence beyond Quality-owned processes across the framework.
• Design and develop, in partnership with Management Review, a model for determining the health of the QMS process ecosystem.
• Consult with Lilly manufacturing, external supplier organizations, marketing affiliate quality operations, research and development, and other functions to educate on the quality system.
• Proactively ensure compliance of Lilly's Quality Systems with various country agency standards, industry trends, and scientific principles.
• Ensure the Global Standard, Processes, Practices, Trainings, and implementation tools are implemented and maintained according to regulatory, industry, and company expectations.
• Implement and continuously improve governance that results in prioritization, decisions at the right level, and enables QMS ease of execution for required changes.
• Ensure processes are executed consistently across the organization and monitor signals to drive continuous improvement.
• Define a common set of global effectiveness and efficiency measures to drive end-to-end QMS health, enable desired performance, and build capability expertise.
• Partner with document owners to obtain potential risks associated with document changes, including regulatory non-compliance, process interruptions, or misalignment between global entities. Develop strategies and contingency plans to mitigate these risks.
• Monitor performance metrics, report, and provide insights to inform decision-making to drive further improvements.
• Develop, lead, mentor, and maintain the GPO community to collaborate on proposed improvements and deepen the knowledge of the associated processes and tools.
• Actively collaborate with enterprise-wide teams on standardized global business processes.
• 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.

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.
• 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.

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 the US Eastern Time Zone. 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 ( ) 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 - $244,200 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. #WeAreLilly Company Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to "take what you find here and make it better and better." More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit. Company info
Location 893 S Delaware St
Indianapolis
Indiana
46285
United States Share this job

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