Associate - Global Quality Compliance (GQC) Operations

Company Name

Eli Lilly and Company

Overview

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.

The Global Quality Compliance (GQC) Operations Associate will work in collaboration with the Quality Systems-Global Process Owner for Document Management to maintain the Global Quality System for Document Management. The GQC Operations team supports all GQC's functional areas by providing key process controls and management of information critical to area operation. The Operations team provides document management, on-boarding, knowledge management, IT process, audit and compliance support to the GQC organization. The Associate will execute strategic deliverables for the global document management process, including the implementation of the quality system architecture, documents, business processes, implementation tools, and associated IT systems. Additionally, the GQC Operations Associate will be an integral member of the Document Management Community of Practice, facilitating and participating in key global projects and priorities within the Quality Management System.

Key Objectives/Deliverables

• Deliver, Monitor, and Maintain Quality System Documents in Vault QMS
• Provide QA Review for Quality System documents in Vault QMS
• Maintain the Document Management quality system to drive standardization globally.
• Design and develop procedures, required tools, and other implementation tools according to regulatory, industry and company expectations
• Provide support for the implementation of improvement initiatives and demonstrate a robust compliance mindset.
• Execute documentation processes consistently across the organization and monitor signals to drive continuous improvement.
• Participate as a member of a community of cross-functional SMEs to collaborate on proposed improvements and deepen the knowledge of the associated local and global processes & tools.
• Maintain and continuously improve GQC functional area business processes

Basic Requirements

• 3+ years of experience in the pharmaceutical industry in GxP roles.
• Bachelor’s degree in Natural Science, Engineering, Pharmacy, or other Life Science-related field.
• Experience in administration of QMS documents and Vault Quality Docs.
• Demonstrated strong knowledge of GxPs and quality management systems.

Additional Skills/Preferences

• Proven ability to work in a matrixed organization with diverse teams and influencing areas not under direct control.
• Proficiency in addressing operational challenges through structured approaches and innovative solutions.
• Demonstrated change agility in anticipating and working with others through change and ambiguity.
• Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate at all levels through various formats.
• Capable of navigating and ensuring adherence to global regulatory standards and frameworks.
• Excellent oral and written communication skills, ability, and willingness to communicate clearly and succinctly with team members and customer organizations.
• Prior experience executing the process or influencing the team supporting creation, revision, obsolescence, and archival of QMS related documents.

Additional Information

• This position is located onsite in Indianapolis, Indiana.

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 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 $63,000 - $140,800.

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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