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.
At Lilly, we believe in the talent of our workforce. One of the best ways to utilize and develop that talent is to use our existing workforce to fill new and/or open positions. If you are looking for a new position within Lilly, you can view and apply to open roles posted in the internal job posting system. You must meet the minimum qualifications outlined in the job description and have/obtain work authorization in the country the position is located in order to be considered. When applying internally for a position, your current supervisor will receive notification that you have applied to the position. We encourage employees to discuss the opportunity with their supervisor prior to applying.
Position Description
The Sr. Principal Associate - Quality and Regulatory Intelligence Systems is responsible to assure the external monitoring systems (e.g. Redica Quality Intelligence and Metric Stream Regulatory Change Management) related integrations, reporting and analytics, and artificial intelligence (AI) tools are designed and operated in compliance with the Lilly Global Quality System (QS) standards and practices using Global Information Technology solutions. This role provides business quality oversight to support the enhancement releases, governing procedures, validation and testing for global monitoring and intel systems. In addition, this role will collaborate with Learning and Development to develop onboarding and training strategies and resources for new users globally. Also, the Sr. Principal Associate is a key member of project teams working with Tech@Lilly to optimize, integrate and automate the way we interact with external intelligence and its connection to internal quality standards and performance across the Lilly enterprise. This role will support implementation of technology solutions that are simplified, sustainable, and compliant throughout Lilly's GxP operations. The Sr. Principal Associate partners with organizations globally to deploy the solutions to achieve quality operational excellence and drive quality culture.
Key Objectives/Deliverables:
The Sr. Principal Associate - Quality and Regulatory Intelligence is responsible for:
Business Quality Assurance
Assuring the computer systems are GMP classified appropriately, designed and operated in compliance with the Lilly Global QS standards and related documents.
Acting as Subject Matter Expert on business requirements for processes to support the tools with consultation with global process owners
Evaluating/assessing the business impact of computer systems
Reviewing and approving business process, change control and validation documentation
Authoring, reviewing, or approving deviations related to the solutions
Providing education, training, and/or communication around the intended use of new 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 requirements and providing understanding of external requirements and their application to business operations
Performance Support Infrastructure (Business Subject Matter Expert)
Spearheading innovative content curation approaches (e.g., videos, performance support, knowledge articles, training, help text, frequently asked questions, job aids) to ensure users have the information they need to do their work in the moment and to prevent human error
Contributing to system design, creating business use cases and executing business testing for new releases and upgrades.
Proposing and implementing innovative system and business process improvements
Creating and updating business process procedures, authority work plans and validation documentation.
Executing MyAccess entity owner role, including required business access/roster reviews
Providing education, training, and/or communication around the intended use of new computer systems or the business impact from changes to existing systems including creation of content and ownership of training strategies
Developing and delivering tools' overview and orientation to new organizations and/or for new functions and support for new users
Troubleshoot and identify system and business process issues; propose and implement improvements and enhancements
Execute primary monitoring role in a backup capacity
Agile Development Team Member
Leading and/or coordinating activities connecting the Quality and Regulatory Intelligence space to Lilly's quality system infrastructure
Assisting in the establishment of site/function deployment approaches
Working across organizations and functions to establish effective partnerships and processes
Working closely with Tech@Lilly partners and system vendors
Participating in project governance
Assisting with organizational change management activities for implementation
Measuring to demonstrate the delivery of value to the enterprise
Work with Business Process Owner and Tech@Lilly to prioritize new features or upgrades of the systems to enable greater efficiencies through automation and AI.
Collaborate with Tech@Lilly and Global Quality Compliance partners to define and prioritize opportunities for building automation and AI connectivity between monitoring tools and quality systems to streamline impact assessments and enable digital connectivity between signals and Lilly quality requirements.
Develop business cases and business plan impact for tool expansions, enhancements or integrations.
Developing and delivering tool to new user groups and additional features/functions.
Basic Qualifications
BS, MS, or PhD in a field of science, engineering, pharmacy, or medicine
5+ years of experience in the pharmaceutical industry, in areas of cGMPs/cGxP's
Demonstrated experience with understanding and use of quality systems and the external regulatory environment
Demonstrated experience in IT solution delivery and support
Additional Skills and Preferences
Demonstrated leadership acumen, including project leadership
Innovative, adaptable, flexible, and open minded, capable of driving change
Strong desire to learn and drive implementation of artificial intelligence integrated solutions
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
Lean, 6 sigma, Black Belt, or Competitive Continuous Improvement coach experience preferred
Additional Information
Job may require travel for personal development and vendor interactions
Job is based primarily in Indianapolis with consideration for other Lilly manufacturing sites.
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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