Manager - Quality Transformation Office

Lupin; New Jersey; On-site; USD 90,000 - 110,000; Full time

Job summary

Lupin in New Jersey seeks a Manager, Quality Transformation Office (QTO) to lead global Quality Control and Laboratory Transformation initiatives. You will modernize analytical labs via digitalization, automation, and emerging technologies to improve efficiency, data integrity, and performance.

The role collaborates with QC, IT, Regulatory, R&D, and Manufacturing to deploy LIMS, CDS, ELN, and analytics dashboards, while driving governance, CAPA, and continuous improvement across the network.

Qualifications

• Bachelor’s degree in relevant science or engineering; Master’s preferred.
• 7–10 years in Pharmaceutical Quality Control and cGMP labs.
• Experience with analytical testing, PAT, spectroscopy (NIR/Raman), and lab modernization.
• Hands-on with LIMS, digital labs, data analytics, and automation.

Responsibilities

• Quality Control & Laboratory Transformation roadmap development and execution.
• Digital Laboratory & Data Analytics: implement LIMS/CDS/ELN and analytics dashboards.
• QMS Harmonization & Continuous Improvement: standardize lab quality systems and drive continuous improvement.
• Cross-Functional Program Management: lead transformation projects across QA, Manufacturing, Regulatory, R&D, IT.

Skills

Quality Transformation

Project management

Data analytics

Regulatory compliance

Laboratory operations

Leadership

Education

Bachelor’s degree in Pharmacy/Chemistry/Life Sciences/Engineering

Master’s degree preferred

Tools

LIMS

ELN

CDS

Automation tools

PAT

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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