3 дня назад
Senior Specialist, QA Clinical Auditor
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Specialist, QA Clinical Auditor (GCP/Clinical Quality): Leading risk-based GCP audits across clinical investigator sites, trials, service providers, processes, and systems with an accent on regulatory compliance, audit strategy, and CAPA oversight. Focus on planning complex audits, analyzing data and trends, supporting regulatory inspections, and delivering clear audit reports.
Location: São Paulo or São José dos Campos, Brazil; ability to comply with J&J Flex way of working. Up to 30% domestic and international travel may be required.
Company
Johnson & Johnson develops healthcare solutions and medicines through its Innovative Medicine and MedTech businesses.
What you will do
- Plan, conduct, and report routine GCP quality assurance audits independently.
- Support non-routine audits, including clinical investigator site, trial, program, service provider, process, system, and local operating country audits.
- Apply audit procedures, tools, plans, corporate standards, and applicable regulatory requirements.
- Analyze data, identify patterns and trends, and ensure timely review and delivery of CAPAs and audit actions.
- Support GCP audit strategy, risk-based audit planning, and regulatory inspections.
- Present findings clearly, prepare audit reports, complete required training, and contribute to quality projects.
Requirements
- Bachelor’s degree.
- At least 5 years of experience in auditing, clinical trial operations, or a related field.
- Knowledge of drug development, clinical research and development practices, quality terminology, GCP, FDA regulations, EU CTR, and ICH E6 R3.
- Understanding of clinical trial risk management, standard operating procedures, good documentation practices, and records management.
- Experience with standard applications, systems, and data analytics tools, with the ability to plan and prioritize work under time constraints.
- Advanced or fluent English speaking and writing skills required.
Nice to have
- Clinical quality assurance audit experience.
- Experience interpreting global regulatory standards and supporting FDA, EMA, or other inspectorate inspections.
- Familiarity with emerging technologies and analytics applied to QA audit processes.
- Conflict resolution, networking, relationship-building, and multi-project management skills.
Culture & Benefits
- Inclusive work environment focused on diversity, dignity, and individual contribution.
- Work within R&D Quality to strengthen compliance, reliability, and quality as a business differentiator.
- J&J Flex way of working.
- Opportunity to contribute to treatments and healthcare solutions that support patients.
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