4 дня назад
Commercial Quality Management Systems (CQMS) Execution Director
150 000 - 258 750$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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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