Associate Director \u2013 Lab Systems

2 days ago


Hyderabad India Lilly Full time

Job Description About the Technology Organization:u202Fu00A0 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 u2013 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.u202Fu00A0 u00A0 About the Business Function:u00A0 From molecule to market, Global Manufacturing plays an important role in every step along a productu2019s 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.u00A0u00A0 Global Manufacturing comprises a core group of functions that contribute to the production and supply of high-quality products: Engineering Manufacturing Information & Control Systems (MI&CS) Technology Services/Manufacturing Science Global Health, Safety and Environment and Global Supply Chain.u00A0 Job Title: Associate Director u2013 Lab Systems & Data (QC Labs) u00A0 The Associate Director will lead and manage our LabVantage LIMS (Laboratory Information Management System) technology initiatives within our pharmaceutical operations. u00A0The Associate Director will ensure that LabVantage technology supports high-quality, compliant, and efficient laboratory operations aligned with business objectives. Key Responsibilities:u00A0 What youu2019ll be doing:u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Labvantage/ Lab systems Support ou00A0u00A0 Provide strategic and operational leadership for LabVantage LIMS configuration and lifecycle management, ensuring alignment with business processes and regulatory standards working with global stakeholders. ou00A0u00A0 Oversee Empower CDS, SmartLab ELN, and Darwin (or equivalent data platforms), ensuring seamless interoperability and compliant data flow across systems. ou00A0u00A0 Define and manage the digital lab ecosystem roadmap, ensuring systems are integrated, scalable, and support global harmonization. u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 System Configuration, Enhancement & Governance ou00A0u00A0 Lead a team responsible for configuring, validating, and maintaining LabVantage modules, including sample management, methods, instruments, and stability. ou00A0u00A0 Establish strong system governance frameworks, including change control, release management, and documentation aligned to GxP and Part 11 requirements. ou00A0u00A0 Partner with IT, QA, and business stakeholders to prioritize enhancements and manage vendor relationships effectively. u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Data Management & Analytics Enablement ou00A0u00A0 Drive data integrity, accuracy, and standardization across laboratory and manufacturing data systems. ou00A0u00A0 Enable centralized data analytics and visualization using LabVantage, Darwin, or connected data lakes to support QC and manufacturing insights. ou00A0u00A0 Ensure data traceability and interoperability between LIMS, CDS, ELN, and ERP/MES systems for end-to-end digital continuity. u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Digital Transformation & Continuous Improvement ou00A0u00A0 Champion digital lab initiatives, including paperless workflows, method automation, and instrument integration to improve efficiency and compliance. ou00A0u00A0 Identify and implement process optimization opportunities through data-driven insights, automation, and AI/ML-ready data foundations. ou00A0u00A0 Collaborate with global and site stakeholders to standardize processes and enable consistent, high-quality system usage. u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Compliance & Audit Readiness ou00A0u00A0 Ensure all systems operate in compliance with GxP, 21 CFR Part 11, Annex 11, and data integrity guidelines. ou00A0u00A0 Maintain validated states of all systems through periodic reviews, assessments, and revalidations. ou00A0u00A0 Support internal and external audits by ensuring system documentation, access controls, and data trails meet regulatory expectations. u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Leadership & Capability Development ou00A0u00A0 Build and lead a high-performing team of LIMS administrators, business analysts, data engineers, and validation specialists. ou00A0u00A0 Develop internal capability in lab informatics, data integration, and analytics to reduce dependency on external vendors. ou00A0u00A0 Foster a culture of innovation, compliance, and collaboration, empowering the team to deliver sustainable, value-driven digital solutions u00A0 u00A0 How you will succeed:u00A0 u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Deliver an Integrated, Compliant Digital Lab Ecosystem: By harmonizing LabVantage, Empower, SmartLab, and Darwin systems to enable seamless data flow, standardized workflows, and regulatory compliance across all QC and manufacturing sites. u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Transform Data into Actionable Insights: Through strong data governance and analytics enablement, turning laboratory and manufacturing data into intelligence that drives faster, more informed decision-making. u00B7u00A0u00A0u00A0u00A0u00A0u00A0 Build High-Performing, Future-Ready Teams and Processes: By developing a skilled informatics team, fostering cross-functional collaboration, and driving continuous improvement to sustain long-term digital transformation and operational excellence. What you should bring:u00A0 u00B7u00A0u00A0u00A0u00A0u00A0 Deep LabVantage and QC Domain Expertise:u00A0 Proven experience in configuring, validating, and governing LabVantage modules for QC labs, with a strong grasp of analytical methods, instrument lifecycle, and GMP workflows. u00B7u00A0u00A0u00A0u00A0u00A0 Strong Compliance and Data Integrity Mindset: In-depth understanding of GxP, 21 CFR Part 11, and ALCOA+ principles to ensure systems, processes, and data meet global regulatory expectations. u00B7u00A0u00A0u00A0u00A0u00A0 Digital Transformation and Integration Capability: Ability to drive lab digitalization by integrating instruments, automating data capture, and enabling paperless, standardized, and globally scalable QC operations. u00B7u00A0u00A0u00A0u00A0u00A0 Leadership and Cross-Functional Influence: Skilled in leading high-performing teams, partnering with Quality, IT, and Manufacturing functions, and aligning global stakeholders toward a unified LIMS strategy. Basic Qualifications and Experience Requirement:u00A0 u00B7u00A0u00A0u00A0u00A0u00A0 Bacheloru2019s or Masteru2019s degree in Life Sciences, Pharma, Engineering, Computer Science, Information Systems, or related field.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0 12+ years of overall experience in the IT Industry with at least 10 years in the pharma industry working with data and minimum 5 years of experience in leading a team.u00A0u00A0 u00B7u00A0u00A0u00A0u00A0u00A0 Exposure to MuleSoft or similar integration platforms.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0 Strong understanding of manufacturing operations, MES, ERP, and LIMS systems.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0 Proven experience in leading cross-functional technology teams and driving complex projects.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0 Excellent problem-solving, communication, and stakeholder management skills.u00A0 u00A0 Additional Skills/Preferences:u00A0 u00B7u00A0u00A0u00A0u00A0u00A0 Knowledge of industrial IoT, digital manufacturing, and smart factory concepts.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0 Experience with data analytics platforms and reporting tools.u00A0 u00B7u00A0u00A0u00A0u00A0u00A0 Strong strategic thinking and ability to align technology initiatives with business objectives.u00A0 u00A0 Additional Information:N/Au00A0 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. Lillyu00A0does 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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