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 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 Sr. Principal - Deviation Mentor is a key member of the Quality Assurance (QA) team, responsible for teaching, mentoring, and guiding deviation and analytical 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 Sr. Principal -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.

Key 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 postapproval 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 the TrackWise platform to Veeva for the CONCORD site.
• Collaborate with the global One QMS team to align site deliverables and timelines.
• Present progress reports on One QMS implementation to site leadership, including key actions and timelines.
• Act as the Power User and Site Instructor for the One QMS Veeva system, covering deviations, change controls, and CAPA.
• Author and review documentation as a Subject Matter Expert for the CONCORD site’s One QMS.

Qualifications:

• Bachelor’s or Master’s degree in a scientific or technical field (e.g., chemistry, biology, microbiology, engineering).
• 5+ years of experience in the pharmaceutical industry.
• Strong technical writing, critical thinking, and organizational skills.
• Demonstrated ability to work cross-functionally with strong interpersonal and teamwork capabilities.
• Good knowledge of cGMP, regulatory standards, and quality system requirements.

Preferred Attributes:

• 10+ 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.

Other Information:

• Occasional off-hours or weekend support for 24/7 manufacturing operations.
• Travel: Up to 10%.

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

$111,000 - $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.

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