Sr. Principal - Site Deviation Program Owner

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.

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.

Job Description

The Deviation Management Program Owner is a member of the QA & Compliance team and plays a pivotal role in ensuring quality and safety of our products through the establishment and continuous improve of the site deviation program. This role is responsible for all aspects of the site deviation management program including but not limited to preparing procedures and training materials, qualifying lead investigators, facilitating deviation review meetings, and monitoring program performance. Additionally, this role will defend the site deviation management program in regulatory inspections and collaborate in site inspection readiness program and assist and advice the lead investigators, functional leaders and Site Quality Leader and Quality Directors in issue investigation matters.

Key Objectives/Deliverables

• Prepare/author deviation management procedure(s) that meet Lilly’s Global Quality Standards and cGMP requirements.
• Prepare/author deviation management training materials.
• Establish qualification program for deviation lead investigators.
• Lead/Participate in investigation forums such as initial triage, initial impact assessment, investigation strategy meetings, root cause and CAPAs alignment meetings.
• Provide advice and guidance to lead investigators in deviation investigation and analytical investigations (assessment, quality impact evaluation, root cause analysis method), investigation write-up (technical writing), support data, etc.
• Measure, monitor, and report Key Performance Indicators (KPIs) to Site Management
• Approve manufacturing and analytical deviation investigations, either as technical or quality approver, including observation deviations and moderate deviations.
• Trained as a lead investigator and deviation assessor and approver.
• Stay abreast of changes in regulations, guidelines, and industry trends related to pharmaceutical quality assurance and proactively implement necessary updates to the deviation management program.
• Serve as a subject matter expert on deviation management matters during regulatory inspections and internal reviews, ensuring successful outcomes and compliance with requirements.
• Integrate global initiatives related to the deviation management program into the site quality standards and processes.
  
  
  

Basic Requirements

• BSc in chemistry, biology, engineering, or equivalent scientific degree
  
  
  

Additional Preferences

• Excellent technical writing skills
• Strong Influencing Skills and interpersonal and teamwork skills
• Good knowledge of cGMP, external Regulations and Lilly Quality Systems requirements
• Proficiency with computer systems including Microsoft Office products, Trackwise, Veeva
• Experience with Active Pharmaceutical Ingredient / Drug Substance operations (chemical and/or peptide synthesis, purification, isolation and drying)
• Experience with laboratory investigations
• 7 or more years of experience in GMP manufacturing (at least 5 years in QA)
• Demonstrated ability to analyze data, identify trends, and implement proactive measures to mitigate risks and improve quality performance
• Excellent problem-solving skills, with the ability to lead root cause analysis investigations and implement corrective and preventive actions (CAPAs) effectively
• Proficiency in deviation management tools and methodologies (e.g., risk assessment, root cause analysis, FMEA) and software systems
• Strong organizational skills, attention to detail, and ability to prioritize and manage multiple projects concurrently in a fast-paced environment
  
  
  

Other Information

• Travel (domestic and international) may be required.
  
  
  

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.

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