Associate - Quality Assurance - Deviation Mentor at Lilly

Concord, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

26 Apr, 26

Salary

162800.0

Posted On

26 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Deviation Investigation, Root Cause Analysis, Technical Documentation, Collaboration, Continuous Improvement, cGMPs, Quality Systems, Regulatory Expectations, Analytical Problem-Solving, Technical Writing, Communication Skills, Deviation Management, Training Programs, Deviation Trending, Inspection Readiness, Cross-Functional Leadership

Industry

Pharmaceutical Manufacturing

Description

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. The Deviation Mentor plays a critical role within the Quality Assurance (QA) organization, providing expertise, guidance, and training for deviation and laboratory investigations. This position is responsible for strengthening investigation quality, supporting inspection readiness, and leading select complex investigations. Key Responsibilities Deviation Investigation Leadership Guide and coach investigators in conducting high-quality deviation investigations, including root cause analysis, impact assessment, and technical documentation. Support reviewers and approvers by providing subject matter expertise in investigation practices. Lead complex or high‑risk investigations as needed. Participate in or facilitate deviation review boards, ensuring thorough evaluations for both pre‑approval and post‑approval stages. Contribute to deviation trending, monitoring, and reporting activities. Design and deliver training programs focused on investigation skills and deviation management. Develop and maintain site‑specific metrics related to deviations and investigations. Qualifications Bachelor’s or Master’s degree in a scientific or technical discipline (e.g., Chemistry, Biology, Microbiology, Engineering). 5+ years of experience in pharmaceutical manufacturing operations; parenteral experience preferred. Strong technical writing and analytical problem‑solving capabilities. Excellent communication skills with the ability to provide clear, constructive feedback. Demonstrated ability to support collaboration, continuous improvement, and high‑quality documentation practices. Solid understanding of cGMPs, quality systems, and regulatory expectations. Preferred Attributes 7+ years of QA experience in pharmaceutical or medical device industries. Experience with deviation management systems such as Veeva or TrackWise. Proficiency in CAPA, change control, and product complaint processes. Hands‑on experience supporting or preparing for regulatory inspections. Exposure to parenteral product materials and processes. Proven ability to influence and lead cross‑functional teams or project implementations. Additional Information Some off‑hours or weekend coverage may be required to support 24/7 operations. Travel up to 10%, primarily domestic. Primary work location: Concord site (on‑site presence expected). Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $63,000 - $162,800 Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly 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! #WeAreLilly

Responsibilities

The Deviation Mentor leads and coaches investigators in conducting high-quality deviation investigations and supports inspection readiness. They also design training programs and contribute to deviation trending and reporting activities.