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.
Lilly’s Purpose
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 35,000 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.
This is an opportunity you don’t want to miss!
Lilly is entering an exciting period of growth, and we are committed to delivering innovative medicines to patients around the world. LRL has increasing needs for in-house manufacture of material for clinical supplies and will therefore construct a new campus to manufacture Clinical Trial (CT) Active Pharmaceutical Ingredient (API) to meet needs for an expanding portfolio (more and new areas), to accelerate development timelines, and to enhance supply chain robustness.
The brand-new facility also known as Lilly Medicine Foundry (LMF) will utilize the latest technology to augment the current clinical supply chain for small molecules (SM), oligonucleotides, peptides, and Antibody Drug Conjugates (ADCs), monoclonal antibodies and bioconjugates, and add new capabilities including mRNA.
The new site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment.
What You’ll Be Doing:
This role will provide CSV technical leadership across the different IT groups in the Lilly Medicines Foundry 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@Lilly and Quality organizations and externally with industry forums and standard to ensure the state of compliance of computer systems.
How You’ll Succeed:
Provide oversight and support of computer systems validation activities, including the review and approval of all documentation issued to support the validation/qualification of non-GMP and GMP systems, as appropriate.
Provide input and execute the risk management approach for CSV for the Lilly Medicine Foundry sites including applying Computer Software Assurance principles.
Act as the primary contact and have principal responsibility for supporting 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 computer-based systems comply with internal and external privacy policies and requirements.
Support Data Integrity readiness for regulatory authority inspections at the Lilly Medicine Foundry 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.
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.
Help determine the GMP designation and testing requirements for computer systems for the Foundry.
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.
Use AI and other automation tools to improve validation and testing processes and productivity
Your Basic Qualifications:
Experience working in a regulated industry (i.e. GMP) and strong understanding of quality processes in IT applying to manufacturing and distribution.
Bachelor’s Degree in relevant fields such as Business Administration, Information Systems, Computer Science or Programming; or BS Engineering (Computer, Electrical, Industrial, Mechanical, Chemical) or equivalent.
Experience writing technical documents, developing business presentations and communicating concepts to a wide range of personnel including senior leadership.
3+ years experience of CSV in a Pharmaceutical Manufacturing domain.
Additional Skills / Preferences:
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.
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 interpret and apply standards to different situations by understanding site needs and applying good problem-solving skills.
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.
Demonstrated learning agility and ability to think creatively; try new ideas and apply learnings.
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.
Strong collaboration with colleagues at all levels.
Demonstrated success in influencing without authority.
Ability to take initiative, to be assertive, to lead by example and to build high-quality relationships.
Highly flexible, adapting to changes in priorities, requirements and processes is required.
System integration experience, including interface design, and familiarity with web-oriented architecture techniques
Understanding of common information architecture frameworks and information models
Demonstrated use or build of CI/CD modern pipelines to ensure software quality
Demonstrated use or build of AI and other automation tools to improve validation and testing processes and productivity
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 (https://careers.lilly.com/us/en/workplace-accommodation) 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
$64,500 - $151,800Full-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, including 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; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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