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12 часов назад

Manager, ERP WMS Leader, Technology Quality (ERP/WMS)

102 000 - 177 100$
Формат работы
onsite
Тип работы
fulltime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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TL;DR
Manager, ERP WMS Leader, Technology Quality (ERP/WMS): Building and executing quality and compliance strategies for enterprise ERP and WMS applications across their full lifecycle with an accent on computerized system validation, preventive controls, and regulatory readiness. Focus on leading global validation programs, approving SDLC documentation, managing audits and inspections, and guiding cross-functional teams through risk-based quality engineering.

Location: Raritan, New Jersey, United States of America; additional job posting location in Horsham, Pennsylvania, United States of America.

Base pay: $102,000–$177,100 per year.

Company

Johnson & Johnson MedTech develops healthcare and medical technology solutions focused on prevention, treatment, and less invasive care.

What you will do

  • Lead end-to-end technology quality and compliance strategies for ERP and WMS applications and supporting infrastructure.
  • Embed preventive and automated quality controls into solution design, development, implementation, maintenance, and retirement.
  • Own validation approaches, approve SDLC documentation and production releases, and provide guidance to project and support teams.
  • Prepare systems for internal and external audits and Health Authority inspections; manage non-conformities, CAPA, incidents, and audit actions.
  • Manage portfolios, project intake, budgets, resources, and large-scale technology quality initiatives.
  • Lead and mentor globally diverse teams while partnering with senior leaders and internal and external stakeholders.

Requirements

  • Bachelor’s degree in Computer Science, Information Systems, Business Administration, or a related field; relevant experience may substitute.
  • 6–8 years of progressive experience in the pharmaceutical, medical device, or biotech industry with direct Computerized System Validation experience.
  • Experience leading large-scale end-to-end validation programs involving systems such as LIMS, CAPA, MES, PLM, SAP, LMS, complaints handling, or change control.
  • Experience managing global technology programs and FTE or consultant teams across multiple geographies.
  • Experience authoring or approving validation protocols, non-conformities, change requests, SOPs, validation plans, and reports.
  • Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Parts 11, 210, 211, and 820.

Nice to have

  • Knowledge of EU Annex 11, SOX, HCC, security and privacy, and ISO regulations.
  • Working knowledge of PMO, SDLC, GAMP 5, and ITIL frameworks.
  • Experience with qTest, JIRA Xray, Agile, SAFe, CI/CD, RPA, cloud computing, IoT, data and analytics, AI, Kubernetes, XaaS, or SaMD.
  • Knowledge of Software Quality Assurance and Software Quality Engineering.

Culture & Benefits

  • Inclusive environment guided by the company’s Credo and focused on diversity and collaboration.
  • Retirement pension and 401(k) savings plans.
  • Vacation, sick time, holiday pay, personal and family time, and parental leave.
  • Bereavement, caregiver, volunteer, and military spouse leave programs.

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