Information Systems Quality Representative - Eli Lilly and Company
Eli Lilly and Company
203 N 10th St
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The ISQ Consultant is responsible for ensuring functional areas, projects, and/or systems for which they are assigned are in compliance with Computer System Validation (CSV) standards. The role must provide independent compliance and quality oversight for the areas they support. This includes facilitating and gaining alignment (both business and IT) on implementing a risk based approach for validating computer systems or qualifying platforms. Using comprehensive business and technical knowledge the associate provides consulting and interpretation of Elanco Quality Standards and Elanco Functional Procedures by setting validation approach based on risk, consulting on ITC processes and services, providing consultation on CSV, and maintaining awareness of corporate and external standards as they relate to CSV. The associate makes quality decisions that impact a range of standard and nonstandard operational, process, project and services
General IT Compliance and Quality Support:
Drive compliance culture within the business area or discipline
Build key relationships with business partners to ensure an overall state of compliance is achieved and maintained
Consulting with Functional Areas regarding Quality Management System components, e.g.,CAPA managementPeriodic reviewsPersonnel qualificationDocument managementIT privacyInformation Security
Participate in self-inspections, audits, and supplier assessment activities to ensure the state of Computer System Validation is clearly and accurately understood
Provide periodic status and compliance updates to IT areas supported and supervision
Provide oversight and direction to the supplier and to maximize the deliverable work performed by the supplier
Understand customer, company, and Quality priorities
Deliver Projects, Programs, and Support
Provide initial project engagement and facilitate validation risk assessments to drive solutions in a quality focused manner
Gain support and ensure System Owners, System Custodians, and project team members are knowledgeable of and engaged in fulfilling their responsibilities in defining, producing, approving deliverables
Provide consulting and CSV interpretation as related to the supported computer systems
Establish key relationships with Business, Business Quality, and IT customer areas to deliver business value for products, processes, and services across the business area
Provide leadership and guidance in driving activities to ensure that IT validation deliverables and other release commitments are completed per the project schedule.
Partner with suppliers of computer systems or services to ensure they meet quality expectations
Orchestrate the creation and maintenance of CSV deliverables for supported areas, including adhoc review and potential authoring of key deliverables based on the areas risk and maturity
Escalate computer system quality issues to the appropriate persons
Understand and communicate the value of CSV
Understand customer, company, and Quality priorities
Provide oversight and ensure regulated and critical systems are validated in compliance with regulations and standards for computer systems.
Review and/or approve documents per CSV expectation within agreed service levels, or clearly communicate when activities will be completed
Streamline and Continuously Improve
Escalate issues appropriately
Promote and advocate for common process and best practice across functions
Identify and pursue opportunities for streamlining and right-sizing that impact multiple functions. This may include elimination of non-value added activities.
Identify systemic issues and trends across functions
Partner with business, business quality, and IT customer areas to deliver business value
Grow Capabilities and Knowledge
Share lessons learned and best practices with others
Act as an engaged team member
Grow capabilities of those performing CSV activities
Deliver training programs to increase understanding/knowledge of CSV
Elanco is a global animal health company that develops products and knowledge services to prevent and treat disease in food animals and pets in more than 90 countries. With a 64-year heritage, we rigorously innovate to improve the health of animals and benefit our customers, while fostering an inclusive, cause-driven culture for more than 5,800 employees. At Elanco, were driven by our vision of food and companionship enriching life all to advance the health of animals, people and the planet. Learn more at .
Bachelor degree in a technology-related field such as Computer Science or Engineering
At least three years of experience in a computer system validation or an information systems quality related role
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
This position is not permanent. It is for a fixed duration of two years with potential to extend annually for up to 4 years.
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
Proficiency with IT systems development life cycle and IT best practices (e.g., ITIL, Agile, etc)
Proficiency with Computer Systems Validation and demonstrated ability to right-size validation based upon risk
Comprehensive business and quality technical knowledge
Previous experience with implementing regulated computer systems
Strong oral and written communication and interpersonal interaction skills
Ability to influence quality peers, IT SMEs, and management
Ability to drive solutions for products, process, and services across a business area
Ability to focus across multiple processes (end-to-end viewpoint)
Broad IT technical competency
Project management skills
Previous experience in regulated (e.g., GMP, GLP, GCP, SOX) environment
Knowledge of Elanco business area
Ability to relate system use to potential impact to products)