Advisor - Global Computer System Auditor

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Job description

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.

For 140 years, Lilly has manufactured medicines that improve people's lives around the world. We produce our medicines using some of the most sophisticated manufacturing technologies and rigorous quality standards. Lilly Manufacturing strives for excellence in its process, standards, procedures and behaviors to develop medicines with safety first and quality always.

Global Quality Auditing and Compliance (GQAAC) is an independent quality unit that provides assurance that Eli Lilly and Company worldwide is in compliance with internal quality standards and regulatory expectations by providing timely, reliable information as to the state of compliance across the value chain and the product life cycle. This position ensures that assessments of computerized systems are performed to determine and report their state of compliance, as well as ensuring that GQAAC has information technology capabilities

available for timely, reliable analysis and reporting of compliance status information.

Key Objectives/Deliverables:

Computer Systems Auditing

• Coordinate development, approval, and completion of an integrated computer systems audit plan across GQAAC
• Work in collaboration with other audit teams and participate in audits as the computer systems expert
• Ensure consistency of audit observations issued related to computer systems (in both application/infrastructure audits and as part of site/third party audits)
• Ensure that appropriate computer system audit metrics are defined, routinely generated, and communicated to appropriate customer groups
• Participate, as needed, as leader/member of computer system audit teams and supports all GxP computer system auditing

GQAAC IT Business Process Owner

• Ensure that GQAAC departmental information technology needs are identified and prioritized by departmental management
• As the GQAAC management representative, coordinate needs with appropriate IT organization(s) to ensure that:
• GQAAC needs are met;
• Solutions are delivered in a timely, organized fashion; and
• GQAAC resources are engaged in a manner that promotes success of the project while minimizing disruptive impact on departmental operations.
  

Computer Systems Knowledge Coordinator

• Identify, develop (if necessary) and oversee processes to ensure consistency across all of GQAAC (and other internal organizations) in:
• Knowledge of current computer technology capabilities and issues
• Interpretation of regulatory agency expectations around computer systems use
• Collaborate with external organizations such as ISPE (GAMP), PDA, etc. in order to develop and maintain an understanding of how Lilly processes around quality aspects of computer systems compares with others in our industry.
• Influence, both internally and externally, how quality of computerized systems should be maintained
• Engage, influence, and provide input to the development/maintenance of corporate computer systems-related standards, policies, and/or procedures
• Coordinate GQAAC computer system audit activities with other Lilly audit functions (such as Corporate Audit Services)
• Stays abreast of new computer system technology and regulations including Artificial Intelligence use for GxP purpose
  

Minimum Requirements:

• Significant relevant experience(s) (minimum of 5-10 years) with quality, manufacturing, or information technology at Lilly or within the pharmaceutical industry.
• Bachelor Degree or equivalent in computer science/technology, pharmacy, physical or biological sciences, engineering or other technical areas of study.
• Ability to interpret and apply regulations, regulatory guidance, codes and public expectations and identify and recommend compliance changes as appropriate.
  

Additional Preferences:

• Knowledge of global drug regulations regarding computer systems preferred

• Excellent interpersonal skills, ability to remain constructive and civil in difficult situations.
• Ability to deliver timely and professional communications (oral and written) with precision and clarity to all levels of the organization.
• Good analytical/problem-solving skills.
• Proven ability to think and analyze from a process perspective. Project management skills.
• Establish and maintain effective working relationships at all levels internal and external to Lilly
• Deliver constructive feedback to customers while providing a high level of customer service.

Other Information:

• Domestic and international travel is required to fulfill these job responsibilities.

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 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women's Network, Working and Living with Disabilities. Learn more about all of our groups.

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