Sr. Director -QMS Operational Controls

Eli Lilly and Company • Indianapolis, IN

125d • $151,500 - $244,200

About The Position

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.

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.

Nice To Haves

• 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.

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.

Benefits

• 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.
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees