Sr. Principal - Deviation Mentor

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. For more than 140 years, we have worked tirelessly to discover medicines that make life better. These discoveries start in Lilly Research Laboratories, where our scientists work to create new medicines that will help solve our world’s greatest health challenges.

Position Brand Description: 

The Deviation Mentor is a member of the QA & Compliance team and teaches, mentors, and guides deviation investigations and analytical investigators. The Deviation Mentor is also responsible for the training program associated to deviation investigations and leads deviation review boards, participates in deviation assessment review pre-approval and post-approval. The Deviation mentor can also lead complex investigations. They participate 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 

• 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. 

• Provide advice and assist deviation reviewers and approvers on issue investigation matters.

• Can lead complex investigations.

• Can act as a technical reviewer for deviation investigations and analytical investigations.

• Can approve deviation investigations, either as technical or quality approver, including observation deviations and moderate deviations. Can approve analytical investigations. 

• Lead and participate in deviation review board: review of deviations prior to deviation approval.

• Lead and participate in the review of the quality of deviation investigations (post-approval). 

• Participate in the elaboration and reviews of deviation trend reports.

• Design and deliver deviation related training program.

• Design and elaborate site deviation and investigation metrics.

• Is trained as a lead investigator and deviation assessor and approver.

• Collaborates in defining the site comprehensive continuous improvement roadmap to ensure the site keeps up to date with regulatory expectations, industry best practices, etc., in particular, with regards to the deviation, non-conformities and discrepancy management program. 

• Coach individuals on inspection interactions. 

• Collaborates in regulatory inspections, assisting in the preparation of key quality and compliance topics for audit and inspection readiness. 

• Integrate global initiatives related to the deviation management program into the site quality standards and processes.

Basic Requirements: 

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

• 3+ year's experience in leading or coaching deviation investigations ​in the Pharmaceutical Industry

Additional Preferences: 

• Demonstrated successful cross-functional teamwork

• Excellent technical writing skills 

• Strong Influencing Skills and interpersonal and teamwork skills 

• Strong self-management and organizational skills 

• Critical thinking skills 

• Good knowledge of cGMP, external Regulations and Lilly Quality Systems requirements 

• Excellent communication skills 

• Proficiency with computer systems including Microsoft Office products, Regulus, TrackWise, PMX, and SAP 

• Experience in TS/MS, Engineering, QC, QA is preferred 

• Experience leading root cause investigations 

Other Information:  

• Minimal 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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