Lilly Deviation Mentor 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.
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 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.
Provide advice and guidance to lead investigators in deviation investigationand analytical investigations(assessment, quality impact evaluation, root cause analysis method),investigationwrite-up (technical writing), support data, etc.
Provide advice and assistdeviation reviewers and approvers on issue investigation matters
Can lead complex investigations
Can act as a technical reviewer for deviation investigationsand analytical investigations
Can approve deviation investigations, either as technicalor quality approver,including observation deviations andmoderate deviations. Can approve analytical investigations.
Leadand participate indeviation review board: review of deviations prior to deviation approval
Leadand participate in the review ofthe quality ofdeviation investigations (post-approval)
Participate in the elaboration and reviewsof deviation trend reports
Design and deliver deviation related training program
Design and elaborate site deviation and investigation metrics
Is trainedas a leadinvestigator and deviation assessor and approver
Collaborates in defining the sitecomprehensivecontinuous improvement roadmap to ensure the site keeps up to date with regulatory expectations, industry best practices, etc., in particular,withregards to the deviation, non-conformities anddiscrepancy management program
Coach individuals on inspection interactions
Collaborates in regulatory inspections, assisting in thepreparation ofkey quality and compliance topicsfor audit and inspection readiness
Integrate global initiatives related to the deviation management program into the site quality standards and processes
Demonstrated successful cross-functionalteamwork
Excellent technical writing skills
Strong Influencing Skills and interpersonal and teamwork skills
Strongself-managementand organizational skills
Critical thinking skills
Good knowledge ofcGMP,external RegulationsandLilly Quality Systemsrequirements
Excellent communication skills
Proficiency with computer systems including Microsoft Office products, Regulus,TrackWise, PMX, and SAP
Experience inTS/MS,Engineering,QC, QAis preferred
BSc or MSc in chemistry, biology,engineering,or equivalent scientific degree
3 or more years in the Pharmaceutical Industry
Experience leading root cause investigations
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 ( 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 in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide valid proof of vaccination to the company.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!