Director – Quality
3 hours ago
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 About the Technology Organization Technology at Lilly builds and maintains capabilities using cutting edge technologies like most prominent tech companies What differentiates Technology at Lilly 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 the enterprise About the Business Function From molecule to market Global Manufacturing plays an important role in every step along a product s lifecycle Most of our customers never see the scientific and technical resources behind our medicines But customers experience every day the performance of our high-quality products and global supply network Global Manufacturing comprises a core group of functions that contribute to the production and supply of high-quality products Engineering Manufacturing Information Control Systems Technology Services Manufacturing Science Global Health Safety and Environment and Global Supply Chain Job Title Director - Quality Shop Floor Execution - Manufacturing Quality This role is accountable for developing implementing and sustaining digital capabilities that enable reliable and compliant pharmaceutical manufacturing This role provides strategic and operational leadership for shop floor execution systems MES DOME integration and Veeva Quality Management System QMS ensuring both systems deliver operational efficiency data integrity and regulatory compliance across global manufacturing sites Key Responsibilities What you will be doing Lead collaboration with global leaders to define and execute a technology roadmap supporting operational excellence digital transformation and data integrity across the manufacturing network Drive convergence across MES automation ERP LIMS and Veeva QMS for seamless data flow and a unified source of truth Implement and continuously improve Manufacturing Execution Systems MES and DOME platforms Oversee integration between MES and ERP systems to enable electronic batch records eBRs materials traceability and paperless manufacturing Lead deployment and optimization of Veeva QMS across manufacturing and quality organizations Ensure integration of Veeva QMS with MES and ERP for connected quality management Manage system uptime cybersecurity and compliance with 21 CFR Part 11 Annex 11 and GxP standards Govern Computer System Validation CSV change management and audit readiness for all systems Lead and mentor IT professionals system owners and business analysts supporting manufacturing and quality systems Manage strategic vendor and partner relationships with providers like Veeva Siemens Rockwell and SAP How You Will Succeed Align technology initiatives with business and regulatory priorities across Manufacturing Quality and Regulatory functions Deliver integrated compliant and high-performing digital solutions enabling right-first-time execution Foster a culture of compliance quality and digital innovation across teams Maintain consistent governance cybersecurity and risk management practices Execute large-scale system deployments effectively within budget and with minimal disruption What You Should Bring Strategic and operational leadership experience in managing enterprise manufacturing and quality systems Strong understanding of GxP CSV and data integrity principles Deep business process knowledge in manufacturing quality and supply chain functions Experience driving cross-functional collaboration and alignment across global teams Proven ability to lead people influence without authority and manage vendors effectively Basic Qualification Bachelor s or Master s degree in Engineering Computer Science or Life Sciences 17 years of progressive experience in IT or Digital roles with at least 5 years in leadership supporting Manufacturing or Quality Strong domain understanding of pharmaceutical biotech quality and shop floor processes At least 5 years in leadership roles within regulated GxP environments Demonstrated success in managing complex global programs and vendor ecosystems Exceptional communication stakeholder management and influencing skills Additional Skills Preferences Strategic mindset combined with hands-on operational execution Strong collaboration and communication skills across Quality Regulatory and Manufacturing functions Experience with platforms such as MES DOME SAP ERP and Veeva QMS Proven change leadership and digital transformation orientation Vendor and stakeholder management expertise in complex global environments 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 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 WeAreLilly
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