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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 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:
1. 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
2. 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
3. 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 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 to prioritize new features or upgrades of the systems to enable greater efficiencies through automation and AI.
- Collaborate with 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 ( ) 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 . click apply for full job details