Associate – Quality Systems Coordinator

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 Associate – Quality Systems Coordinator will provide key oversight in monitoring and tracking quality management system (QMS) execution. This will include tracking key deliverables for completion against stated timelines, influence of best practices in QMS application, and suggesting and driving continuous improvement to ensure conformance to QMS measures.

This position, as assigned is responsible for development and maintenance of an effective and robust Purchasing Controls and Supplier Management / Quality System ensuring consistent application of medical device regulations across IDM and DDCS.

Quality Systems Coordination

• Supply technical guidance on corporate and site quality systems policies and procedures
• Implement and maintain quality systems compliance
• Monitor and track quality systems execution, including periodic reviews of documentation, deviations, change control, quality plans, and corrective and preventive action
• Act as proxy for external third-party action owners, track and obtain responses
• Provide strategic guidance on applying right-sized risk-based approach to corrective and preventive action
• Influence best practices and timeliness of execution
• Support organizational quality systems deployment and continuous improvement activities based upon trends in execution
  
  
  

Supplier Management Support

• Lead, mentor, and coach QA function in improving the IDM/DDCS Supplier Quality Management System, ensuring the development & sustaining of a robust purchasing controls system that guarantees consistent application of device regulations across the Pharmaceutical Delivery Systems (PDS) Network.
• Liaison with Global QA - Procurement to ensure the IDM/DDCS Supplier Quality Management System maintains consistent implementation of the Lilly Global Quality Standards (GQS).
• Support alignment of IDM procedures with Lilly GQS and Common Quality Practices, in addition to, applicable governing standards and regulations.
• Support collection of data/information for site management review.
• Support continuous improvement projects related to supplier management and PDS Quality Management System.
• Ensure supplier quality related issues are assessed for the need of deviations or CAPAs for IDM and DDCS.
  
  
  

Minimum Experience Qualification Requirements

• Ability to influence diverse groups
• Ability to work independently
• Attention to detail
• Problem solving and decision-making skills, with emphasis on data-based decisions, and customer service
• Strong written and verbal communications skills
• Strong administrative and organizational skills
• Teamwork and interpersonal skills
• Minimum of 3 years working in a regulated or cGMP industry
  
  
  

Additional Preferences

• Expertise in applicable internal regulatory standards
• Experience with Microsoft Applications, Veeva, SAP, and Track Wise
  
  
  

Minimum Education Requirements

• Bachelor's Degree (or equivalent work experience)
• Preferably in engineering, science or STEM fields.
  
  
  

Other Information (e.g., Any Required Certifications)

• Work in a dynamic and fast paced environment
• Travel Requirement 0-5%
• This position is located in Indianapolis, Indiana and it does require to be onsite at Lilly 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 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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