R&D Audit & Inspection Associate

Eli Lilly and Company • Us, IN

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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. Purpose: The R&D Audit & Inspection Associate provides essential support, oversight, and education to quality and business personnel concerning various components of the quality system, with a primary focus on Audits and Inspections and Notification to Management (NTM). This role is critical in ensuring GMQO’s readiness for audits and inspections, enhancing quality system components, and supporting continuous improvement efforts with the GMQO Process Owner for Audits and Inspections. General Responsibilities Provides support, monitoring, and education to quality and business personnel for assigned quality system components, including, but not limited to Audits and Inspections, Notification to Management (NTM). Works closely with the GMQO process owner for Audits and Inspections for the monitoring and continuous improvement of the process. Serves as SharePoint Site Administrator (MIM sites) and supports the development and management of a cross functional inspection management infrastructure for logistics, preparation/planning, and close out activities including tracking all sponsor requests and facilitating inspection management response process. Administratively and logistically facilitates and manages backroom for sponsor inspections and audits hosted by Global Medicines Quality Organization. Manages the appropriate archiving of audits and inspections data and retrieval of documentation from various systems to support audits and inspections including master SOP list and documents in long-term storage or eArchive. Performs timely data entry as relates to audit / inspection conduct into Trackwise/Veeva and maintains, analyzes, and facilitates any actions as a result of bi-monthly inspection update metrics used by management and GMQO for inspection readiness. Coordinates routine and ad-hoc mock inspections / rehearsals in collaboration with GMQO. Maintains inspection readiness artifacts including but not limited to: Inspection Distribution List; Inspection Presentations; Inspection Organization Chart; Audit and Inspection Training. Participates in industry forums for inspection readiness information exchange and benchmarking as applicable. Lead, or conduct other projects /tasks as requested in the management of audit and inspection activities. Metrics and Data Responsible for compiling and reporting of audit / inspection compliance metrics at appropriate levels for management review. Performs trend analysis on inspection and audit issues/observations to provide meaningful and actionable data at governance meetings and for use in ongoing inspection readiness. Participates in the preparation of annual audit and self-inspection plans in collaboration with management and GQAAC. Participates in Management Review preparations for audit and inspection data in collaboration with Standard owners and GQAAC.

Requirements

• Bachelor’s degree or High School Diploma and 10 years’ experience in the Pharmaceutical Industry

Nice To Haves

• Experience in Inspection/Audit preparation of Sponsor and related sites (eg clinical sites) within a GCP/GLP/GPvP environment).
• Experience with IT/systems supporting quality; specifically, TrackWise, Notification to Management, SharePoint and Power BI a plus.
• Knowledge of GLP, GCP and GVP global regulations as they relate to Clinical Development, Drug Safety and Drug Development.
• Excellent communication skills, both written and oral.
• Ability to effectively develop and present information to all levels of the organization.
• Prioritize and handle multiple concurrent tasks and good planning and organization skills.
• Work across functions to obtain input, resolve differences, and achieve results.
• Effectively apply judgment-based decision making in a regulated environment.
• Demonstrated ability to assess the state of current business and operations to identify and recommend future state, improvements, and implement action plans.
• Ability to manage complex projects end ‑ to ‑ end, set clear timelines, coordinate cross ‑ functional teams, and keep deliverables on track.
• Strong communication skills with the ability to translate technical or detailed information into clear, actionable updates for diverse audiences.
• Proven track record of maintaining alignment across teams, anticipating risks, and proactively resolving issues to keep projects moving smoothly.
• Understanding of being risk based focused and prioritizing work based on Risk Management methodologies.
• Work in a team matrix environment and independently interact with various levels of management.
• Limited travel: 0-10%

Responsibilities

• Provides support, monitoring, and education to quality and business personnel for assigned quality system components, including, but not limited to Audits and Inspections, Notification to Management (NTM).
• Works closely with the GMQO process owner for Audits and Inspections for the monitoring and continuous improvement of the process.
• Serves as SharePoint Site Administrator (MIM sites) and supports the development and management of a cross functional inspection management infrastructure for logistics, preparation/planning, and close out activities including tracking all sponsor requests and facilitating inspection management response process.
• Administratively and logistically facilitates and manages backroom for sponsor inspections and audits hosted by Global Medicines Quality Organization.
• Manages the appropriate archiving of audits and inspections data and retrieval of documentation from various systems to support audits and inspections including master SOP list and documents in long-term storage or eArchive.
• Performs timely data entry as relates to audit / inspection conduct into Trackwise/Veeva and maintains, analyzes, and facilitates any actions as a result of bi-monthly inspection update metrics used by management and GMQO for inspection readiness.
• Coordinates routine and ad-hoc mock inspections / rehearsals in collaboration with GMQO.
• Maintains inspection readiness artifacts including but not limited to: Inspection Distribution List; Inspection Presentations; Inspection Organization Chart; Audit and Inspection Training.
• Participates in industry forums for inspection readiness information exchange and benchmarking as applicable.
• Lead, or conduct other projects /tasks as requested in the management of audit and inspection activities.
• Responsible for compiling and reporting of audit / inspection compliance metrics at appropriate levels for management review.
• Performs trend analysis on inspection and audit issues/observations to provide meaningful and actionable data at governance meetings and for use in ongoing inspection readiness.
• Participates in the preparation of annual audit and self-inspection plans in collaboration with management and GQAAC.
• Participates in Management Review preparations for audit and inspection data in collaboration with Standard owners and GQAAC.

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees