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我們的全球團隊由 ~ 22,000 名才華橫溢的員工組成,他們的職場文化中,每個聲音都很重要,每一個貢獻都受到讚賞。 我們熱衷於洞察, 創新並致力於為我們的客戶提供最好的產品。憑藉專業知識和同理心,成為 Kenvuer 意味著每天有能力影響數百萬人。我們以人為本,熱切關懷,以科學贏得信任,以勇氣解決——有絕佳的機會等著您!加入我們,塑造我們和您的未來。有關更多資訊,請按兩下 here.
Role reports to:
Head of Proactive Reg Comp and Standards位置:
North America, United States, New Jersey, Skillman工作地點:
混合你會做什麼
Global Compliance Information Manager
The Global Compliance Information Manager provides compliance data analytics for the Kenvue Quality, Compliance & Excellence organization. This position will monitor the global regulatory environment for changing regulations and health authority trending. In addition, this role is responsible for preparing routine department reports/updates, providing as needed metrics, managing compliance data trends, maintaining training, and identify/implement process and data quality improvement opportunities. This position will work closely with the VP, Kenvue Quality, Compliance & Excellence, Regional Compliance Leads, Kenvue Quality Systems, and Kenvue Regulation Management in areas related to compliance data and emerging regulatory trends and requirements.
Collect, analyze, and report global compliance data, including data from Kenvue compliance and quality programs for the following forums:
QHS Regulatory compliance updates
Global Kenvue quality management review
Kenvue Leadership Team and Kenvue Board of Directors reporting
Kenvue’s Healthy Lives Matter public reporting
Ad hoc compliance data trending and reporting for the Global Quality, Compliance & Excellence team
Monitor relevant quality and compliance forums for hot topics and trends both internally (e.g., regulatory compliance data system of record) and externally (e.g., health authority websites/reports, industry monitoring tools).
Develop and issue summary report(s) on compliance information and trends that impact Kenvue businesses.
Maintain department periodic reporting.
Maintain Quality, Compliance & Excellence department processes, data, information, and training.
Support Kenvue regulatory compliance audits/follow-up and inspection readiness
Support Quality, Compliance & Excellence team project initiatives
Required Qualifications
Bachelor’s degree in science (e.g., Biology, Chemistry or related field)
8+ years of experience in Quality Assurance, Regulatory Affairs, Compliance and/or other related areas in a matrixed Life Sciences (Consumer, Pharmaceutical and/or Medical Device) organization
Hands-on experience with quality system and compliance reporting (i.e. data analytics and trending)
Working knowledge of FDA and equivalent Health Authority GMP regulations
Exceptional organization skills
Meticulous attention to detail in reporting with the ability to anticipate obstacles and barriers and mitigate these issues
Excellent communication skills, with the ability to articulate and express concepts clearly and persuasively both verbally and in writing, particularly when simplifying complex regulatory or technical issues
Ability to work autonomously as a high impact individual contributor and manage multiple priorities and deadlines in a fast-paced environment
Working knowledge of compliance and quality systems and tools (e.g., Curve, ETQ, Veeva, Tableau)
Proficiency with MS Excel
Travel: ~10% travel
Desired Qualifications
Understanding of regulatory bodies approach to inspections and how to respond to regulatory body observations
Experience preparing reports and/or data summaries for varying audiences
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本職位新員工年薪底薪範圍:
這考慮了許多因素,包括工作地點、候選人的技能、經驗、教育水準和其他與工作相關的因素
有競爭力的福利待遇**
帶薪公司假期, 帶薪休假、志願者時間 &更多!
學習 &發展機會
Kenvuer Impact Networks
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