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Sr. Principal Associate - Site QA Compliance Auditor

Employer
Eli Lilly and Company
Location
Durham, North Carolina
Start date
Oct 31, 2023

Job Details

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.

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Description:

The QA Representative for Site Compliance serves as Quality oversight for evaluating the RTP Quality Management Systems to ensure that processes are robust and in compliance with applicable cGMP regulations.  The QA Representative will develop tools to enable Lilly to better assess the Quality Culture and QMS performance at RTP.  The QA Representative will engage in open communication and foster an environment of increased accountability while ensuring that an escalation process is in place. 

Responsibilities:

  • Lead, influence, and communicate status of inspection readiness activities to maintain inspection readiness state of the site.
  • Lead site communications and trainings for regulatory authority changes and impact to the site.
  • 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 RTP site auditing and inspection strategy utilizing a risk-based approach.
  • Develop and communicate RTP SSI schedule.
  • Lead/Conduct Site Self Inspections to ensure RTP processes are robust and in compliance with the RTP 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.
  • Provide Support during audits by internal (GQAAC, PDS) and external (Notified Body, FDA, etc.) auditing bodies.
  • Act as site coordinator for compliance gap assessment and ensure applicable corrective actions are implemented via RTP site impact analysis process.
  • Network with Global and Lilly Parenteral and Device Network sites as resources and benchmarking sources as applicable.

Basic Requirements:

  • Bachelor’s degree in a science, engineering, computer, or pharmaceutical related field of study or equivalent industry experience.
  • Previous Experience working in the pharmaceutical or medical device industry in Quality or Regulatory Affairs roles.

Additional Preferences:

  • In-depth knowledge of applicable external global regulations and/or ISO 13485:2016
  • Experience in leading audits
  • 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.
  • Auditing or regulatory certification such as American Society for Quality (ASQ) and/or Regulatory Affairs Certification (RAC, RAPS)
  • Experience with Microsoft Applications, Regulus, SAP, Veeva, and TrackWise

Additional Information:

  • Ability to work 8-hour days – Monday through Friday
  • Ability to work overtime as required.
  • Ability to travel up to 10% to Indianapolis, IN for meetings and coordination with global regulatory organizations.

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.

#WeAreLilly

Company

Science has been our calling from the beginning. Colonel Eli Lilly founded the company in 1876 and charged employees to “take what you find here and make it better and better.” More than 147 years later, we remain committed to his vision through every aspect of our business and the people we serve, starting with discovering the best treatments for those who take our medicines and extending to health care professionals, employees and the communities in which we live. Moreover, you can also count on the team at Lilly to be incredibly civic-minded, supporting our communities through philanthropy, volunteerism, and a creative and innovative can-do spirit. 

Company info
Location
893 S Delaware St
Indianapolis
Indiana
46285
United States

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