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.
Position Overview:
Lilly is actively growing its manufacturing footprint globally to meet the needs of patients and deliver on our exciting future. As a result, Lilly is looking for experienced quality assurance associate to oversee its internal audit and inspection program to support our growth in Kenosha County, Wisconsin.
The Principal Quality Associate serves as the QA Compliance Site Self Inspection (SSI) Quality lead providing oversight for evaluating the Lilly Kenosha County (LKC) Quality Management Systems to ensure that processes are robust and in compliance with applicable cGMP regulations. The QA Compliance Site Self Inspection (SSI) Lead will develop tools to enable Lilly to better assess the Quality Culture and QMS performance at LKC. The QA Compliance Site Self Inspection (SSI) Lead will engage in open communication and foster an environment of increased accountability while ensuring that an escalation process is in place.
Key Responsibilities Include:
Support the QA Compliance team and site in the execution of the site readiness plan with focus on maintaining Audit Management system and site compliance.
Create and maintain applicable quality system SOPs.
Develop the LKC site auditing and inspection strategy utilizing a risk-based approach.
Develop and communicate LKC SSI schedule.
Lead/Conduct Site Self Inspections to ensure LKC processes are robust and in compliance with the Concord QMS and cGMP regulations.
Review audit and inspection responses and verify implementation of corrections and CAPA.
Create inspection and audit reports.
Maintain and present Audit Program metrics.
Lead site communications and trainings for regulatory authority changes and impact to the site.
Lead and influence inspection readiness activities to maintain inspection readiness state of the site.
Provide support during audits by internal and external (Notified Body, FDA, etc.) auditing bodies.
Function as site coordinator for compliance gap assessment and ensure applicable corrective actions are implemented via LKC site impact analysis process.
Network with Global and Lilly Parenteral sites as resources and benchmarking sources as applicable.
Complete and Submit an Annual Self-Assessment Compliance Form to evaluate the effectiveness of the Records Management Program as the Principle Records and Information Manger (PRIM).
Basic Requirements:
Bachelor's degree in a science, engineering, computer, or pharmaceutical related field of study or equivalent industry experience.
Minimum 5+ years experience working in the pharmaceutical or medical device industry in Quality or Regulatory Affairs roles.
Minimum 3+ years experience supporting and/or leading audits
Additional Skills/Preferences:
Auditing or regulatory certification such as American Society for Quality (ASQ) and/or Regulatory Affairs Certification (RAC, RAPS), preferred.
Experience with Microsoft Applications, SAP, Veeva, and TrackWise
Demonstrated strong oral and written communication and interpersonal interaction skills.
Attention to detail and strong organizational skills.
Demonstrated strong technical writing skills.
Demonstrated teamwork and interpersonal skills.
Additional Information:
Ability to work 8-hour days - Monday through Friday
Ability to work overtime as required.
Ability to travel up to 10%
Additional travel may be required for initial mentoring and onboarding, including potential for a Short-Term Assignment
The position is for the LKC site requires on-site presence.
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
$63,000 - $162,800
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.