M&Q Sr. Director - Digital Quality Labs, Execution and TSMS, Tech at Lilly MQ

Eli Lilly and Company•Indianapolis, IN

5d•Onsite

About The Position

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. M&Q Sr. Director Digital Quality labs, execution and TSMS, Tech at Lilly MQ Organization Overview: At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing, and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism. Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing around the world to create new state-of-the-art manufacturing site’s and continue expanding our existing facilities to created capacity required to continue with our mission. The brand-new facilities will utilize the latest technology, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. Join us in transforming Lilly’s Quality Control (QC) Lab Information and Execution, autonomous labs, Product Lifecycle Management (PLM) and Digital CMC ! Lilly has launched a multi-year QC Digital Labs transformation to streamline and advance its Digital Lab agenda. This initiative supports broader company growth and the delivery of new treatment modalities worldwide.

Requirements

Must have a strong understanding of corporate computer system validation requirements according to Lilly Quality Standards, providing technical guidance to the global and site teams ensuring quality of operations and deliverables.
Must have a combination of technical and soft skills to effectively collaborate with cross-functional teams and drive continuous improvement with Quality Lab processes, TSMS Digital agenda and Labs.
Must communicate technical information to non-technical stakeholders, influence decision making at all leadership levels, adept at networking and building strong professional relationships.
Proactively monitor and stay abreast of evolving business and technology trends, in the realm of Digital Quality Labs in Manufacturing. Continuously seek out innovative approaches to enhance our processes.
Experience with cGMP regulations, Data Integrity requirements in a highly regulated environment. Strong understanding of Lab Council business processes, QC equipment and Instruments, Lab automation, Method development and harmonization, QC Technology Transfer process, Computer System Validation.
Leverage an agile mindset and framework for the entire lifecycle.
Development of QC Equipment Product Market Place, Standards, Technology Packages, Digital Tech Transfer , Product Lifecycle Management (PLM) Vendor Management , Resource Management, Third party engagement and governance
Coach and mentor team members on best practices and standards enabling scaling.
Experience with Manufacturing sciences, Digital Tech Transfer, Quality Digital lab processes, Lab Data Integration, Lab technology Standardization, Quality lab automation.
Experience with Good Manufacturing and laboratory Practices with demonstrated experience in computer system validations efforts.
Understanding of eRelease, Sample Management and tracking, method development and standardization etc.
Excellent communication and interpersonal skills to build relationships with stakeholders and articulate complex technical concepts.
Experience working with modern technology stack including cloud-based solutions, Artificial Intelligence.
Bachelors or Master’s degree in computer science, Information Technology, Engineering or related technical field.
With a minimum of 7+ years in IT leadership roles, Quality and Manufacturing strategies driving strategic initiatives and fostering team growth.
7+ years of leadership experience leading, delivering and/or supporting enterprise IT platforms within a highly regulated industry

Nice To Haves

Labvantage LIMS and LES, NuGenesis, EMPOWER, BINOCS, IoT edge, QBDVision PLM in Manufacturing and Quality domain
Lab automation systems, Instrument integrations, development, and/or support.
Excel in negotiation, driving consensus across complex stakeholder groups to achieve desired business outcomes.
Combine assertiveness with effective change management.
Passion for working on a team from diverse backgrounds and geographies.
Familiarity with Agile ways of working, Product framework

Responsibilities

Advance the Digital Lab of the Future, encompassing Lab Information Management, Lab Execution, autonomous labs, Process PLM, and the Digital agenda within Technical Services and Manufacturing Sciences (TSMS).
Provide strategic leadership over the digital lab portfolio and establish governance for Digital Quality Labs across the organization.
Lead transformation initiatives to digitalize laboratories and implement emerging technologies in close collaboration with QC and TSMS teams.
Work alongside peer leaders and management from QC and TSMS to deliver MQ digital transformation programs within QC Operations and TSMS.
Provide leadership and guidance to the Tech team and its resources.

Benefits

eligible for a company bonus (depending, in part, on company and individual performance)
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)

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