Associate - Quality Assurance - Deviation Mentor

Eli Lilly and Company • Concord, NC

27d • $63,000 - $162,800

About The Position

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 is a key member of the Quality Assurance (QA) team, responsible for teaching, mentoring, and guiding deviation and laboratory investigations. This role oversees the training program related to deviation investigations, participates in deviation assessments (pre-approval and post-approval), and may lead complex investigations. The Deviation Mentor also collaborates in regulatory inspections, site inspection readiness, and issue resolution. In addition, this role will serve as the site steward for One Quality Management System (One QMS) during the project phase.

Requirements

• Bachelor’s or Master’s degree in a scientific or technical field (e.g., chemistry, biology, microbiology, engineering).
• 5+ years of experience in pharmaceutical manufacturing operations with preference for parenteral manufacturing
• Strong technical writing, critical thinking, and organizational skills.
• Exceptional communication and interpersonal skills, with a proven ability to provide constructive, actionable feedback to enhance technical document clarity and quality.
• Demonstrated talent for fostering a collaborative environment where open dialogue and positive critique drive continuous improvement in deviation writing practices.
• Good knowledge of cGMP, regulatory standards, and quality system requirements.

Nice To Haves

• 7+ years in QA roles within the pharmaceutical or medical device industry.
• Experience with GMP systems, including Deviation Management and Document Control systems.
• Advanced technical proficiency in deviation management, CAPA, change control, and product complaint handling.
• Regulatory inspection experience, including readiness and execution
• Familiarity with TrackWise, Veeva, and parenteral product materials.
• Proven ability to lead global or local project implementations and influence cross-functional teams.

Responsibilities

• Deviation Investigation & Guidance Provide expert guidance to lead investigators on deviation investigations, including root cause analysis, quality impact evaluations, and technical writing.
• Assist and advise deviation reviewers and approvers on issue investigation matters.
• Lead complex investigations and act as a technical reviewer for deviations and analytical investigations.
• Lead or participate in deviation review boards, ensuring thorough pre-approval and post-approval reviews.
• Support the development and review of deviation trend reports.
• Design and deliver training programs related to deviations and investigations.
• Develop site-specific deviation and investigation metrics.
• One QMS Responsibilities Manage the transition of the Quality Management System (QMS) from TrackWise to Veeva for the Concord site.
• Collaborate with the global QMS I3 team to align site deliverables and timelines.
• Present progress reports on QMS I3 implementation to site leadership, including key actions and timelines.
• Act as the Power User and Site Instructor for the QMS I3 Veeva system, covering deviations, change controls, and CAPA.
• Author and review documentation as a Subject Matter Expert for the Concord site’s QMS I3 implementation.

Benefits

• 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).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees