Director – Quality

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.

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