6 дней назад
Pharmacovigilance QA Auditor Specialist
79 000 - 127 650$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Pharmacovigilance QA Auditor Specialist (Pharmacovigilance and Quality Assurance): Planning, conducting, and reporting internal and external pharmacovigilance audits with an accent on audit compliance, data analysis, and business partner collaboration. Focus on supporting regulatory inspections, evaluating GxP and non-regulated processes, and resolving complex compliance issues.
Location: Hybrid position based in Raritan, NJ; Titusville, NJ; or Horsham, PA, United States. Requires 25% domestic and/or international travel.
Salary: $79,000–$127,650 annually
Company
Johnson & Johnson MedTech develops healthcare and medical solutions, alongside Innovative Medicine products designed to improve patient outcomes.
What you will do
- Lead the planning, execution, and reporting of routine internal and external pharmacovigilance audits.
- Support audits of data, internal facilities, and processes in GxP and non-regulated areas.
- Support regulatory inspections in various roles.
- Consult with business partners on routine compliance tasks and inquiries.
- Collaborate on complex compliance issues and help establish unified departmental positions.
- Participate in assigned projects and prepare training materials when needed.
Requirements
- Bachelor’s degree required; a life science, natural science, or computer science degree is preferred.
- At least 4 years of relevant pharmacovigilance experience.
- Strong project management, verbal and written communication, and presentation skills.
- Strong teamwork, collaboration, data analysis, critical thinking, and attention to detail.
- Experience with Microsoft Outlook, PowerPoint, Excel, and Word.
- Availability to work in the listed United States locations and travel 25% domestically and/or internationally.
Nice to have
- Broad understanding of auditing processes and the audit landscape.
- Experience with various audit types.
Culture & Benefits
- Inclusive work environment guided by the company’s Credo.
- Retirement pension and 401(k) savings plans.
- Vacation, sick time, holiday pay, and personal and family time.
- Parental, bereavement, caregiver, volunteer, and military spouse leave programs.
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