Quality Transformation Lead – Digital Lab Modernization

Lupin; Northern (KY); Hybrid; USD 90,000 - 110,000; Full time

Job summary

Lupin USA seeks a Manager to lead Quality Transformation Office initiatives across the global manufacturing network. The role focuses on modernizing analytical laboratories through digitalization, process optimization, automation, and emerging technologies to boost efficiency, compliance, data integrity, and laboratory performance.

The position requires strong experience in pharmaceutical QC, cGMP labs, PAT, NIR/Raman, LIMS, and digital platforms.

Qualifications

• Bachelor’s degree in a related discipline is required.
• Master’s degree preferred in a related field.
• 7–10 years of progressive experience in Pharmaceutical Quality Control and cGMP-regulated laboratories.
• Strong experience in analytical testing, laboratory operations, PAT, spectroscopy technologies (NIR/Raman), and laboratory modernization programs.
• Hands-on experience with LIMS, digital laboratory platforms, data analytics, and automation initiatives.

Responsibilities

• Develop and execute global QC and Laboratory Transformation roadmap aligned with corporate objectives.
• Drive laboratory modernization through digitalization and automation.
• Pilot and deploy advanced technologies including PAT, NIR/Raman, rapid analytical methods, automated sample management, and smart laboratory solutions.
• Benchmark industry best practices and emerging technologies to drive continuous innovation in laboratory operations.
• Partner with QC, IT, and Digital Transformation 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.
• Lead standardization and simplification of laboratory-related quality systems including OOS, OOT, investigations, 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.
• Lead strategic transformation projects involving Quality Control, Quality Assurance, Manufacturing, Supply Chain, Regulatory Affairs, R&D, Engineering, and IT.
• Manage program governance, project milestones, risks, dependencies, and benefits realization.
• Support deployment of the Global Quality Roadmap with a focus on laboratory excellence and digital transformation.
• Facilitate communities of practice, workshops, knowledge-sharing forums, and change management initiatives to accelerate adoption of new technologies and ways of working.

Skills

Analytical testing

Lab operations

PAT

NIR spectroscopy

Raman spectroscopy

LIMS

Automation

Data analytics

cGMP compliance

Education

Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, Biotechnology, Engineering, or related discipline

Master’s degree or postgraduate qualification preferred

Tools

LIMS

CDS

ELN

Analytics dashboards

Job description

Lupin USA seeks a Manager to lead Quality Transformation Office initiatives across the global manufacturing network. The role focuses on modernizing analytical laboratories through digitalization, process optimization, automation, and emerging technologies to boost efficiency, compliance, data integrity, and laboratory performance.

The position requires strong experience in pharmaceutical QC, cGMP labs, PAT, NIR/Raman, LIMS, and digital platforms.