Job Information
Lilly M&Q Sr. Director Digital Quality Assurance systems and Technical Services/Manufacturing Sciences, Tech at Lilly MQ in Indianapolis, Indiana
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 Assurance systems and Technical Services/Manufacturing Sciences, 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.
Come help us transform Lilly’s Quality Management and Product Lifecycle Management System !
Lilly has initiated a multi-year Quality Management System transformation program that will simplify and enhance Quality Management at Lilly. This is part of a broader set of enterprise wide programs focused on enabling unprecedented company growth and delivery of new modalities serving patients around the world.
What You’ll Be Doing
Your primary role as Global M&Q Sr. Director, Tech at Lilly is leading One Lilly Next Generation Quality Management System (QMS) and also sustaining our current Quality Assurance and Audit Systems (QA). In addition, enable digital technologies in Technical Services/Manufacturing Sciences (TSMS). In this role, you will provide leadership with our Digital Quality portfolio and governance for Quality Assurance space across the enterprise, lead TSMS Digital transformation initiatives to digitalize the Product and Process Definition(s), Process Product Lifecycle System (PLM). You will partner with your peer leaders, QA leadership, TSMS leaders, Data domain leaders to support existing solutions, deliver the MQ digital transformation programs in Quality and TSMS. You will have a leadership role in coaching, development of resources, and staffing a global group.
How You’ll Succeed
Be Bold - We are looking for a leaders at all levels to tackle tough challenges and ability to coach through translation of complex business requirements into robust business process and data solutions.
Be Fast - We need someone who is willing to move at the pace of MQ and the Growth of the organization.
Be Engaging - We need a leader who will engage a broad and diverse team focused on re-imagining Quality and Manufacturing processes using automated solutions, bring new capabilities such as Artificial Intelligence, next generation platforms using modern API’s and tech stack.
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 and TSMS leaders.
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, Manufacturing Control Strategies. Continuously seek out innovative approaches to enhance our processes.
Experience with cGMP regulations, Data Integrity requirements in a highly regulated environment.
Strong understanding of QMS business processes, Manufacturing, Development Technology Transfer process, Computer System Validation.
Leverage an agile mindset and framework for the entire product lifecycle.
Coach and mentor team members on best practices and standards.
What You Should Bring
Experience with QMS processes, implementing enterprise Quality Management System.
Experience with Good Manufacturing Practices with demonstrated experience in computer system validations efforts.
Understanding of Complaints management, Deviation Management, CAPA, Change Management, Quality Risk Management 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.
Additional Experience in the following would be preferred but not required:
o Veeva Vault Quality, Trackwise, Veeva Quality Docs, Kneat Validation Execution, Metric Stream, Process PLM in Manufacturing and Quality
o Manufacturing Execution System (MES) or manufacturing systems integrations i.e ISA-S95, development, and/or support.
Your Basic Qualifications
Bachelor's degree in computer science, Information Technology 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.
Must have relevant leadership experience leading, delivering and/or supporting enterprise IT platforms within a highly regulated industry
Additional Preferences
Masters degree in computer science, Information Technology or related technical field.
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
About the Organization
Lilly IT builds and maintains capabilities using groundbreaking technologies like most prominent tech companies. What differentiates Lilly IT is that we create new possibilities through tech to advance our purpose – creating medicines that make life better for people around the world, like data driven drug discovery and connected clinical trials. We hire the best technology professionals from a variety of backgrounds, so they can bring an assortment of knowledge, skills, and diverse thinking to deliver innovative solutions in every area of our business.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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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