Manager - Quality Transformation Office

Lupin•Franklin Township, NJ

1d•$90,000 - $110,000•Onsite

About The Position

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.

Requirements

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

Nice To Haves

Master's Degree or postgraduate qualification preferred.

Responsibilities

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.
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.
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.
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.
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.