Associate

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-QA Quality Systems and Regulatory Compliance role is part of the Lilly Pharmaceutical Delivery Systems (PDS) Quality Systems and Regulatory Compliance team. The team provides support and oversight of the Lilly PDS Devices network of global sites and internal/external suppliers. This role shall provide key expertise to the network and team on application of existing and new standards, regulations, and guidance with regards to medical devices and device constituents of combination products within the Lilly portfolio.

The Associate QA-IDM (Quality Systems and Regulatory Compliance) will report to the Quality Senior Director and will have responsibility for coordinating the development and maintenance of Technical Files and Technical Documentation for new and existing products, external surveillance and intelligence on global device regulations, CE marking support of new devices. This role also supports hosting of regulatory inspections and performing quality system gap analyses against existing and upcoming new regulations. Additionally, this role may have responsibility for assessing Pharmaceutical Delivery Systems (PDS) functional areas, contract manufacturers, applicable affiliates and ISO certified sites as an auditor (as assigned based upon business need) against the PDS Quality Management System to ensure that processes are robust and in compliance with the PDS QMS, ISO 13485 requirements and applicable global medical device and combination product regulations.

Responsibilities:

• Lead and coordinate PDS/IDM impact analysis of global regulatory changes and Lilly Quality Standards

• Coordinate development and maintenance of Technical File and Technical Documentation

• Support CE marking of new products

• Create and maintain applicable quality system SOPs

• Lead/Conduct audits as assigned

• Create audit reports

• Review audit responses and verify implementation of corrections, corrective actions and preventive actions

• Provide support for audits by internal (GQAAC) and external (Notified Body, FDA etc.) auditing bodies

• Support organizational continuous improvement initiatives

Basic Qualifications:

• Bachelors Degree preferred

• 5 years' experience in Quality or Regulatory Affairs preferred

Additional Skills/Preferences:

• Auditor certification (ASQ CQA) and/or Regulatory Affairs Certification (RAC, RAPS)

• In-depth knowledge of internal standards, applicable external medical device and combination product global regulations and ISO 13485

• Experience with Microsoft Applications, SAP, Veeva, and TrackWise

• 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

Additional Information:

• Travel up to 10% of the time (Including International)

• This position is located 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 ( ) 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

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.