Principal Associate - Qa Compliance Site Self Inspection (Ssi)

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:
Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 billion to create a new state-of-the-art manufacturing site, in Concord, North Carolina. The brand-new facility will utilize the latest technology to increase the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site. The Lilly Concord site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. This is an opportunity you don't want to miss!
Position Description:
The QA Compliance Site Self Inspection (SSI) Lead serves as Quality oversight for evaluating the Concord 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 Lilly Concord. 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.
Responsibilities:

• 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 Concord site auditing and inspection strategy utilizing a risk-based approach.
• Develop and communicate Concord SSI schedule.
• Lead/Conduct Site Self Inspections to ensure Concord 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 Concord 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.
• In-depth knowledge of applicable external global regulations and/or ISO 13485:2016
• Experience in leading audits
• 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:

• The position is for the Lilly Concord site and during the project phase will allow for a flexible working environment with the ability to periodically work remotely based on the project phase and site activities.
• 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

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.
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.
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