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4 дня назад

Commercial Quality Management Systems (CQMS) Execution Director

150 000 - 258 750$
Формат работы
onsite
Тип работы
fulltime
Грейд
director
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
Commercial Quality Management Systems (CQMS) Execution Director (Quality Systems/MedTech): Leading commercial quality management system governance, product traceability, and labeling controls across healthcare operations with an accent on risk-based execution, regulatory compliance, and process harmonization. Focus on standardizing QMS processes, enabling digital and analytics improvements, managing audit and compliance risks, and developing a global quality team.

Location: Titusville, New Jersey, or Horsham, Pennsylvania, United States. Candidates must already have authorization to work in the United States; immigration sponsorship and relocation support are not available.

Base pay: $150,000–$258,750 per year.

Company

Johnson & Johnson MedTech develops healthcare solutions and medical technologies designed to prevent, treat, and cure complex diseases.

What you will do

  • Lead Commercial Quality Management Systems governance and execution across multiple QMS elements.
  • Own QMS strategy with local operating companies, regional teams, and cross-functional stakeholders.
  • Oversee product traceability, end-to-end labeling, labeling controls, and related GxP activities.
  • Drive risk-based quality management, harmonization, standardization, continuous improvement, and adoption of QMS processes.
  • Use digital enablement, automation, analytics, and QMS insights to improve performance and support senior leadership decisions.
  • Build networks, manage quality and compliance risks, and lead, coach, and develop a global team.

Requirements

  • Bachelor of Science or equivalent degree; Engineering, Science, Technical, or Quality disciplines are relevant.
  • At least 10 years of experience in a highly regulated industry, including 10 or more years in healthcare Quality Systems and at least 5 years managing Quality Systems.
  • Experience in the pharmaceutical or medical device industry, with people leadership and senior stakeholder collaboration.
  • Broad knowledge of Quality Engineering, Quality Assurance, Quality Systems, Supplier Quality, Regulatory, and Quality Compliance.
  • Strong knowledge of current GMPs, FDA and international regulatory requirements, quality terminology, risk management, and external audits.
  • Written and spoken English proficiency and existing authorization to work in the United States are required.

Nice to have

  • Master’s degree in Quality or Regulatory.
  • Expert knowledge of U.S. Quality System Regulations and ISO 13485.
  • Experience translating enterprise standards into efficient, risk-based, harmonized processes.
  • Experience with process and platform optimization, digital enablement, analytics, and value realization.

Culture & Benefits

  • Inclusive work environment focused on diversity, dignity, and individual contribution.
  • Eligibility for pension, 401(k), and long-term incentive programs.
  • Vacation, sick time, holidays, personal and family time, parental, bereavement, caregiver, volunteer, and military spouse leave.
  • Collaboration with Commercial Quality, Regulatory Affairs, Supply Chain, Safety, Medical Affairs, Commercial, health authorities, notified bodies, and international regulatory authorities.

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