Quality Management System Deviation Lead at Lilly

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.

Position Description

The Quality Management System Deviation Lead provides strategic oversight and expertise for the global Deviation and CAPA processes, including Global Quality System standards, procedures, business processes, implementation tools and associated IT systems. Additionally, this role manages key global projects and priorities within the Global Quality System.

Key Objectives:

Support general QMS Organizational Change Management activities, ongoing deployment support and troubleshooting support to ensure end users are proficient with system and process expectations.
Facilitation of cross-functional education sessions, including Deviation and CAPA Communities of Practice for best practice and knowledge sharing and training programs to deepen the Deviation knowledge and expertise.
Provide Root Cause Analysis subject matter expertise to ensure robust problem solving remains a strong core competency for all deviations.
Monitor all Deviation and CAPA KPIs at Global level to assess health of deviation system and identify areas of opportunity across the enterprise.
Lead Deviation and CAPA projects to support continuous improvement efforts, including revalidation and user acceptance testing for all system improvements implemented.
Analyze Deviation and CAPA data to monitor site/function performance to ensure processes are executed consistently across the organization and monitor signals to drive continuous improvement. Support sites/functions, as needed, to develop improvement plans.
Act as Deviation and CAPA procedure SME and facilitate procedure updates when required to ensure consistent execution and/or as a result of regulatory feedback.
Act as a SME for Deviation Artificial Intelligence tools, ensuring user feedback and learnings are considered to continuously improve the model outputs to improve quality of deviation write ups.
Engage in external organizations and industry organizations to monitor policy changes for regulatory / external environments and advocate / influence quality related policies and regulatory requirements related to Deviations and CAPAs.

Basic Qualifications

Bachelor's Degree in a field of science, engineering, pharmacy, or medicine.
Minimum 10 year experience in the pharmaceutical industry

Additional Skills/Preferences:

Extensive hands on deviation management and analytical investigation experience required. Hands on experience with other QMS processes desired.
Lean, 6 sigma, Black Belt, or Competitive Continuous Improvement coach experience preferred
Demonstrated leadership acumen, including project leadership
Demonstrated ability to build and maintain collaborative relationships with external/internal stakeholders; navigate complex issues and find common ground with multiple constituencies with differing, and often opposing, perspectives.
Strong collaboration, negotiation, problem solving, and interpersonal skills. Proven record of finding and implementing solutions.

Demonstrated ability to write technical documents, develop business presentations, and effectively communicate the concepts to a wide range of personnel.

Additional Information

Ability to travel 10-20% (domestic and internationally).
Potential for role to be based at any Lilly M&Q site.

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

$65,250 - $169,400

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

Quality Management System Deviation Lead

Support general QMS Organizational Change Management activities, ongoing deployment support and troubleshooting support to ensure end users are proficient with system and process expectations.

Facilitation of cross-functional education sessions, including Deviation and CAPA Communities of Practice for best practice and knowledge sharing and training programs to deepen the Deviation knowledge and expertise.

Provide Root Cause Analysis subject matter expertise to ensure robust problem solving remains a strong core competency for all deviations.

Monitor all Deviation and CAPA KPIs at Global level to assess health of deviation system and identify areas of opportunity across the enterprise.

Lead Deviation and CAPA projects to support continuous improvement efforts, including revalidation and user acceptance testing for all system improvements implemented.

Analyze Deviation and CAPA data to monitor site/function performance to ensure processes are executed consistently across the organization and monitor signals to drive continuous improvement. Support sites/functions, as needed, to develop improvement plans.

Act as Deviation and CAPA procedure SME and facilitate procedure updates when required to ensure consistent execution and/or as a result of regulatory feedback.

Act as a SME for Deviation Artificial Intelligence tools, ensuring user feedback and learnings are considered to continuously improve the model outputs to improve quality of deviation write ups.

Engage in external organizations and industry organizations to monitor policy changes for regulatory / external environments and advocate / influence quality related policies and regulatory requirements related to Deviations and CAPAs.