IT Analyst - Lebanon, United States - Lilly

Lilly

Verified Company

Lebanon, United States

1 week ago

Posted by:

Mark Lane

beBee recruiter

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.

Organization Overview:

This role will provide CSV technical leadership across the different IT groups in Lilly Lebanon focused on external regulations, industry best practices, policies and procedures governing the process to validate, maintain and retire new and existing computer systems.

The position will be responsible for defining and maintaining CSV local policies and procedures to ensure that all solutions deployed are developed and implemented according to enterprise policies and regulatory requirements.

This role will collaborate within the Lilly Tech at Lilly and Quality organizations and externally with industry forums and standard to ensure the state of compliance of computer systems.

Responsibilities:

Oversight and support of computer systems validation activities, including the review and approval of all documentation issued to support the validation/qualification of nonGMP and GMP systems, as appropriate
Provide input and execute the risk management approach for CSV for the Lilly Lebanon sites.
Acts as the primary contact and has principal responsibility for supporting all internal and external CSV related audits and privacy related inspections, working in collaboration with Computer Systems Quality Assurance on GMP related systems. Also responsible for privacy initiatives to ensure that all computerbased systems comply with internal and external privacy policies and requirements
Support Data Integrity readiness for regulatory authority inspections at the Lilly Lebanon site and if required, effectively represent the company during regulatory audits through interaction/ discussion with regulatory officials related to data management and integrity.
Anticipate short term and future needs of the function to focus. Enable and influence business effectiveness by identifying opportunities for leveraging technology
Maintain the organization's System Development Life Cycle (SDLC) ensuring that current business and regulatory requirements are satisfied. Establish a framework to monitor and audit adherence to SDLC.
Collect, evaluate and prioritize opportunities to improve compliance, privacy, and SDLC related policies and procedures. Report, analyze, audit and develop plans and programs to support continuous quality improvement.
Participate in business plan activities and in appropriate site governance and steering teams.
Help determine the GMP designation and testing requirements for analytics tools.
Must have working understanding of compatibility, integration, interoperability, stability, scalability and usability of products/services being implemented to ensure validation activities cover all requirements
Must ensure security and privacy risks are considered in the design and testing of IT systems

Basic Qualifications:

Bachelor's Degree in relevant fields such as Information Systems, Computer Science or Programming; or BS Engineering (Computer, Electrical, Industrial, Mechanical, Chemical) or equivalent

Additional Preferences:

Ability to communicate effectively in written and verbal form (in English), with proven success at delivering key messages to both management and peers across multiple business functions
Demonstrated ability to write technical documents, develop business presentations and effectively communicate concepts to a wide range of personnel including senior leadership
Strong collaboration with colleagues at all levels
Demonstrated courage & integrity
Demonstrated success in influencing without authority
Ability to take initiative, to be assertive, to lead by example and to build highquality relationships
Highly flexible, adapting to changes in priorities, requirements and processes is required.
Demonstrated proficiency in planning and the ability to carry out tasks with a high degree of independence as well as being able to work in a team environment
Strong knowledge and technical expertise in areas of cGMPs, processes, production practices, and quality systems
Recognized understanding of regulations governing CSV and data integrity
Speak up with ideas as well as concerns and ensure the psychological safety of others.
Business acumen, and the ability to communicate to executives, business domain stakeholders and technical staff alike
Experience with innovation and ideation methods, such as design thinking.
System integration experience, including interface design,