Manager - Quality Transformation Office

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

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.

Key Responsibilities

1. 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.
2. 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.
3. 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.
4. 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.
5. 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, knowledge-sharing forums, and change management initiatives to accelerate adoption of new technologies and ways of working.

Qualification and Experience

• • Bachelor’s degree in pharmacy, Chemistry, Life Sciences, Biotechnology, Engineering, or related discipline.
• • Master's Degree or postgraduate qualification preferred.

• • Minimum 7 to 10 years of progressive experience in Pharmaceutical Quality Control and cGMP-regulated laboratory environments.
• • 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.

The anticipated salary range for this position in New Jersey is $90,000.00 - $110,000.00, plus discretionary performance bonus (based upon eligibility). The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Lupin is a multi-state employer, and this salary range may not reflect positions that work in other states.

Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veteran’s status, or any other classification as required by applicable law.

The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environment.

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