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Lilly Sr. Principal Associate - Quality & Compliance in Indianapolis, Indiana

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 35,000 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.

To provide support to the Parenteral Site by ensuring compliance to Lilly Standards and Industry regulations. The Site Quality Assurance Representative provides oversight of the CAPA and Change Management Process. Additionally, the Site Quality Assurance Representative provides compliance support to the site through internal audits and monitoring of all Quality Systems at the site. The Site Quality Assurance consultant also provides significant support to external inspections by Lilly’s GQAAC and regulatory agencies.

Responsibilities:

  • Provide site expertise on assigned Quality Systems with a strong understanding of requirements and serves as the liaison between the site and the Lilly Standards owner when needed.

  • Ensure site compliance to assigned Quality Systems:

  • Lead Site Self Inspections of the Quality Systems.

  • Monitor Lilly Standard revisions to drive site gap assessments to ensure procedural compliance to standards.

  • GQAAC and Regulatory Inspections:

  • Coordinate audit prep room, obtain audit resources and provide site communications.

  • Manage inspection pre-requests.

  • Facilitate the compilation of observation responses at the site, gain senior leadership approval, and submit response.

  • Perform external surveillance through monitoring and trending of industry 483s.

  • Escalate any significant compliance issues identified to the site, Operations, and Quality Management.

  • Provide guidance and recommendations to Parenteral Site associates in support of remediation of significant quality issues and compliance gaps.

  • Participate as required in teams, committees, or other groups to resolve quality issues and ensure site compliance to Lilly Standards and external regulations.

  • Provide technical and quality review of documents.

  • Conduct metric and data evaluation from system monitoring, identify trends, and present results to Parenteral Site leadership.

  • Develop and communicate best practices / training for CAPA process, ensure compliance with procedures, process, and work instructions.

  • Interact with the Global CAPA group and IT support to be involved in TrackWise software changes and provide the necessary administrative duties to implement changes at the Parenteral Site.

Basic Requirements:

  • Bachelors degree (STEM discipline preferred)

  • Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position

Additional Skills/Preferences:

  • Parenteral experience.

  • Relevant industry experience in Quality Assurance, Quality Control, Operations, Engineering or Technical Services.

  • Project Management Skills are preferred, with the ability to work independently.

  • Possess strong technical understanding of methods, processes, and Quality systems.

  • Strong understanding of event and change management and previous experience in the TrackWise system for Event and/or change management.

  • Strong demonstrated ability to communicate with customers, including good oral and written communication skills, as well as presentation skills.

  • Demonstrated problem solving skills and a broad knowledge of finished pharmaceutical manufacturing, storage, and testing operations.

  • Proficiency with computer systems including Microsoft Office products, TrackWise, Veeva, etc.

  • Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.

Additional Information:

  • Day shift, Monday-Friday, overtime may be required.

  • Applicant may work in various areas within the Parenteral Plant. Some allergens are present in the Parenteral Plant.

  • Mobility requirements and exposure to allergens should be considered when applying for this position.

  • Position is located at the Lilly Technology Center - South

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 ( LillyRecruitingCompliance@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.

As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).

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