Sr. Principle Associate - Quality Management System (QMS) Quality Assurance

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 Sr. Principle Associate – Quality Management System (QMS) Business Quality Assurance (BQA) is responsible to assure the Vault QMS system is maintained and operated in compliance and regulations from the quality standards using Global IT solutions. They provide business quality oversight to the corporate systems on behalf of the sites/areas utilizing the system IT tools.  The QMS BQA is a key member of the QMS transformation program, modifying the way core quality management processes (e.g., deviations, CAPA, complaints) are executed across the Lilly enterprise.  As part of the transformation, this role will support implementation of technology solutions that are simplified, sustainable, and compliant throughout Lilly’s GxP operations across the enterprise.  The Sr. Principle Associate partners with organizations globally to deploy and maintain the solutions to achieve quality operational excellence and drive quality culture.

Key Objectives/Deliverables:

The Sr. Principle Associate – QMS BQA is responsible for:

1. Business Quality Assurance

• Assuring the Veeva QMS computer system is designed and operated in compliance with regulations from the quality standards
• Assuring commitments made to regulatory agencies regarding quality business processes are evaluated for impact on the Veeva QMS computer system and any enhancements/changes are made accordingly
• Acting as Subject Matter Expert on business requirements for processes to support the Veeva QMS with consultation with global process owners; point of contact for suggestions, prioritization decisions, developing business cases to secure funding
• Evaluating/assessing the business impact of computer systems changes
• Reviewing and approving validation documentation for delivery & support; authoring, reviewing, or approving deviations related to the Veeva QMS
• Perform required business access/roster reviews
• Providing education, training, and/or communication around the intended use of computer systems or the business impact from changes to existing systems
• Providing consulting support for organizations on the appropriate use of computer systems
• Seeking continual awareness of current industry trends and regulatory agency interpretation of related computer requirements and providing understanding of external requirements and their application to business operations

2. Veeva QMS Performance Support Infrastructure

• Spearheading innovative content curation approaches (e.g., videos, performance support, knowledge articles, training, help text, FAQs, job aids) to ensure users have the information they need to do their work in the moment and to prevent human error

3. Veeva QMS Core Team Member

• Help to establish and lead the change review board
• Leading and/or coordinating activities related to Vault QMS
• Working across organizations and functions to establish effective partnerships and processes
• Participating in project governance
• Measuring to demonstrate the delivery of value to the enterprise

Basic Qualifications

• BS, MS, or PhD in a field of science, engineering, pharmacy, or medicine
• Minimum 5-year experience in the pharmaceutical industry, in areas of cGMPs/cGxP’s
• Demonstrated experience in IT solution delivery and support

Additional Preferences

• Demonstrated leadership acumen, including project leadership
• Demonstrated ability to build and maintain collaborative relationships with 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 solutions
• Demonstrated ability to write technical documents, develop business presentations, and effectively communicate the concepts to a wide range of personnel
• Adaptable, flexible, and open minded, capable of driving change
• Lean, 6 sigma, Black Belt, or Competitive Continuous Improvement coach experience preferred

Additional Information

• Ability to travel (domestic and internationally)
• not approved for Remote work

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.

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