Our client in Central NJ is seeking a Product Leader with deep expertise in Quality IT to drive the strategy, design, and lifecycle management of digital quality systems within their global manufacturing network. This leader will ensure that Quality IT platforms are not only compliant and reliable today, but also architected with a future-ready design philosophy that supports scalability, integration, and innovation across the plant ecosystem. The ideal candidate combines hands-on Quality IT experience (e.g., LabVantage, LabWare, PAS-X, Veeva Vault, ValGenesis) with a strong understanding of manufacturing operations (automation, QA/QC labs, supply readiness, and regulatory compliance). They will champion a design-first approach that balances compliance with agility, ensuring systems remain fit-for-purpose as technologies, therapies, and regulations evolve. Key Responsibilities + Own the vision and roadmap for Quality IT products across manufacturing plants, ensuring alignment with business objectives, GxP regulations, and corporate digital strategy. + Lead the design and architecture of Quality IT systems with a focus on modularity, scalability, and long-term maintainability — avoiding short-term fixes in favor of sustainable, future-proofed solutions. + Guide implementation and optimization of systems such as QMS, LIMS (preferably LabVantage), DMS, eBR/MES (PAS-X), and validation platforms (Kneat/ValGenesis). + Partner with automation teams (e.g., DeltaV, plant DCS systems) to integrate process data with quality systems, enabling review by exception and real-time deviation capture. + Define and oversee integration strategy to ensure seamless data flow between LIMS, MES, ERP (SAP), and enterprise quality platforms (Veeva, TrackWise). + Lead compliance and validation efforts (CSV, Part 11, Annex 11), embedding them into design principles to reduce rework and accelerate plant readiness. + Collaborate with QA, QC, Manufacturing, and IT stakeholders to ensure systems support both immediate operational needs and long-term digital maturity goals. + Drive vendor engagement, selection, and governance, ensuring vendor roadmaps align with future-proof Quality IT strategy. + Track and communicate KPIs and quality metrics related to deviations, CAPA effectiveness, cycle time reduction, and system reliability. + Stay ahead of emerging technologies (AI/automation, predictive analytics, digital twins) and translate them into a forward-looking Quality IT strategy. Qualifications + 10+ years of experience in Quality IT leadership roles within life sciences (biotech, pharma, or cell/gene therapy). + Deep expertise in Quality systems: + LIMS (LabVantage highly preferred; LabWare, STARLIMS, or equivalent acceptable) + QMS (Veeva, TrackWise, Sparta, MasterControl) + DMS (Veeva Vault QualityDocs, OpenText) + MES/eBR (PAS-X, Syncade, POMSnet) + Validation lifecycle tools (Kneat, ValGenesis) + Strong working knowledge of manufacturing plant ecosystems: automation (DeltaV, SCADA), QA/QC lab workflows, batch release processes, and regulatory expectations. + Proven success leading cross-functional teams and delivering enterprise-wide system integrations. + Solid understanding of CSV, Part 11 compliance, GMP/GDP/GxP requirements, and audit readiness. + Demonstrated ability to apply a design-first, future-proofing mindset in building IT product strategies. + Excellent stakeholder management skills — ability to bridge IT, Quality, Manufacturing, and Regulatory perspectives. + Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field (advanced degree preferred).Preferred Experience + Experience supporting CAR-T, biologics, or advanced therapy manufacturing plants. + Track record of designing Quality IT solutions that scale across sites, adapt to new modalities, and integrate with evolving technology landscapes. + Strong vendor and partner management skills, with the ability to influence product roadmaps. + Comfort operating in global, multi-site environments with complex regulatory landscapes. If interested, please apply or email Kim.Ladka@experis.com to schedule a conversation. ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.