Sr. Principal - Global Quality Systems Lead

Lilly•Indianapolis, IN

4d•Hybrid

About The Position

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 Sr Principal (R4+) – Global Quality Systems Lead will provide oversight and support of QMS processes under Global Process Ownership for non-Quality owned processes. The role additionally ensures 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 role supports the QMS Pillar leads for the health, management, and reporting across the Operational Controls pillar of the QMS framework. Additionally, the GQS Lead will support QMS excellence by supporting the aligning of processes with business priorities, ensuring compliance, and driving quality improvements.

Requirements

Bachelor’s Degree or equivalent in scientific field (e.g., Chemistry, Bio-chemistry), engineering, or related field.
Strong knowledge of cGMP and quality systems with a minimum of 7 years of direct cGMP experience.
Demonstrated experience in one or more of the following areas or modalities: Quality Control Labs Cell and Gene Therapy Parenteral Manufacturing
Demonstrated learning agility to learn new modalities, QMS areas, and new technologies.
Knowledge of Lean and continuous improvement methodologies to develop and continuously improve processes.
Demonstrated ability to interpret and apply standards to different situations by understanding customer needs and applying good problem-solving skills.
Proficiency in planning and carrying out tasks with a great degree of independence, and as part of a team, with minimal supervision and ability to travel.
Demonstrated ability to communicate and deliver constructive feedback to customers, including oral, written and presentation communication skills.
Demonstrated ability to develop business presentations and effectively communicate the concepts to a multiple range of personnel.
Previous regulatory inspection readiness and inspection execution experience
Proficient with the usage of the MS Office suite (e.g. Word, Excel, PowerPoint, Access, Project, Visio).

Nice To Haves

Experience in the following quality systems: Quality Risk Management Process and Equipment Validation Cleaning and Sterilization GMP Utilities Sterility Assurance Bioburden Controls
Formal training in Lean and Continuous improvement methodologies
Formal training in Quality Risk Management
Detailed knowledge of US and European GMP’s, ICH, PIC/S, and WHO
Continuing education / master’s degree or higher in science related field (e.g., Chemistry, Bio-chemistry).
Previous facility or area start up experience, including equipment and process validation support.
Fluent in English; additional languages are also recommended.

Responsibilities

Support and provide oversight for Global Process Owners (GPOs) of non-Quality-owned processes to deliver process excellence in the Pillars of the QMS framework, including the development, review, and approval of Quality Systems documents.
Provide consulting support to GPOs, Communities of Practice, Area Process Owners, and Network areas on interpretation and implementation of Lilly global quality systems.
Support the GQS structured governance and monitoring model to deliver excellence beyond Quality-owned processes across the framework.
Support and conduct Management Review for determining the health of the QMS process ecosystem.
Lead and/or support the assessment, development and implementation of global quality projects in support of continual Global Quality System improvements.
Consult with Lilly manufacturing, external supplier organizations, marketing affiliate quality operations, research and development, and other functions to educate on the quality system.
Proactively work with Global Process Owners to 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.
Help 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.
Support the monitoring of performance metrics, report, and provide insights to inform decision-making to drive further improvements.
Support the development of the GPO / APO 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

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
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).

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