Manager - Quality Transformation Office
Lupin Ltd · Somerset, NJ · 3 wk ago
Quality Assurance$90k/yrFull-time
About the role
The Manager, Quality Transformation Office (QTO), will drive Quality Control and Laboratory Transformation initiatives across the global manufacturing network. The role will focus on modernizing analytical laboratories through digitalization, process optimization, automation, and deployment of emerging technologies to improve efficiency, compliance, data integrity, and laboratory performance.
Responsibilities
- Quality Control & Laboratory Transformation
- Develop and execute the global Quality Control and Laboratory Transformation roadmap aligned with Corporate Quality and business objectives.
- Drive laboratory modernization through digitalization, automation, and implementation of next-generation analytical technologies.
- Evaluate, pilot, and deploy advanced technologies including Process Analytical Technology (PAT), NIR/Raman spectroscopy, rapid analytical methods, automated sample management, and smart laboratory solutions.
- Benchmark industry best practices and emerging technologies to drive continuous innovation in laboratory operations.
- Digital Laboratory & Data Analytics
- Partner with QC, IT, and Digital Transformation teams to advance LIMS-enabled digital laboratories across the network.
- Drive implementation and optimization of laboratory digital platforms including LIMS, CDS, ELN, analytics dashboards, and automation tools.
- Ensure seamless integration of laboratory systems, workflows, and data architecture to support end-to-end digital quality operations.
- QMS Harmonization & Continuous Improvement
- Lead standardization and simplification of laboratory-related quality systems including OOS, OOT, laboratory investigations, method lifecycle management, deviations, CAPA, and change control.
- Identify systemic compliance gaps and implement best practices aligned with FDA, EMA, MHRA, WHO, PIC/S, and ICH expectations.
- Drive continuous improvement initiatives focused on right-first-time results, productivity enhancement, and reduction of laboratory cycle times.
- Cross-Functional Program Management
- Lead strategic transformation projects involving Quality Control, Quality Assurance, Manufacturing, Supply Chain, Regulatory Affairs, R&D, Engineering, and Information Technology.
- Manage program governance, project milestones, risks, dependencies, and benefits realization.
- Capability Building & Change Management
- Support deployment of the Global Quality Roadmap with a focus on laboratory excellence and digital transformation.
- Facilitate communities of practice, workshops,