Sr. Principal Associate Quality and Regulatory Intelligence Systems

Eli Lilly-posted 8 months ago
$63,000 - $162,800/Yr
Senior
Onsite • Indianapolis, IN
Chemical Manufacturing
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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.

  • 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.
  • Spearheading innovative content curation approaches 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.
  • 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.
  • 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 closely with Tech@Lilly partners and system vendors.
  • Participating in project governance.
  • Assisting with organizational change management activities for implementation.
  • Collaborating 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.
  • 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.
  • 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.
  • Strong collaboration, negotiation, problem solving, and interpersonal skills.
  • 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.
  • 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.
  • Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).
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