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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$121,500 - $178,200

Responsibilities:

The Advisor – QA, Global Quality Systems serves as the lead Business Quality Assurance representative for the enterprise-wide electronic Document Management System (eDMS) and is part of the Global Quality Systems (GQS) organization.

The Advisor – QA, Global Quality Systems is responsible for assuring that the eDMS computer system (QualityDocs) is operating in compliance with regulations and Lilly Global Quality System standards.

Key Objectives/Deliverables:

The QA Advisor, Global Quality Systems is responsible for:

Representing business area requirements within QualityDocs and influencing the future direction of the application.
Supporting QualityDocs design improvements via appropriate prioritization and decision making while ensuring standardized design solutions for the enterprise.
Delivering QualityDocs led releases to implement new functionality and enhancements to meet business priorities.
Supporting the validation processes for QualityDocs, including vendor and Lilly releases as the Business QA representative.
Reviewing and approving validation deliverables, deviations, and changes, as required.
Leading and managing projects, understanding business impact, quantifying resources, and evaluating technical options.
Engaging internally with Senior Quality Leadership to influence changes to the Lilly Quality Management System.
Working externally to influence Veeva’s QualityDocs application capabilities and fluxionality to meet business and compliance needs.
Consulting with site/global QA/QC/CSQ to resolve related quality issues.
Providing leadership to QualityDocs Design SMEs in determining configuration design, defining requirements, maintaining training and performance support material, and executing user acceptance testing.
Providing consultation / education to sites / business areas on the interpretation and implementation of quality requirements as it relates to QualityDocs.

Basic Requirements

8+ years direct experience in pharmaceutical setting.
BS in scientific discipline
Strong knowledge of GxP and quality systems with a minimum of 5 years of direct GxP quality experience related to Manufacturing and Medical/Regulatory/Safety.
Demonstrated experience managing documents or configuration changes within an eDMS (electronic document management system)

Additional Skills/Preferences:

Direct experience managing documents or configuration changes within QualityDocs.
Demonstrated ability to interpret and apply standards to different situations by understanding customer needs and applying good problem-solving skills.
Demonstrated ability providing Quality support to IT systems/tools that support quality processes..
Proficiency in planning and ability to carry out tasks individually and as part of a team, with minimal supervision.
Demonstrated ability to interact with and support IT systems/tools that support quality processes (e.g., QualityDocs).
Demonstrated ability to communicate and deliver constructive feedback to customers, including good oral, written and presentation communication skills.
Demonstrated ability to develop business presentations and effectively communicate the concepts to a multiple range of personnel.
Experience with Agile processes and methodology.

Additional Information:

Able to attend training courses, conferences, or association meetings to continue to gain knowledge, to share such information with other members of the group or company to increase awareness and to train others in the implementation of these practices.
Must be fluent in English, additional languages are also recommended
Role can be based at any US manufacturing location.

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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, 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 help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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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Eli Lilly

QA Advisor, Global Quality Systems 5 Locations

Eli Lilly