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7 дней назад

Quality Assurance Associate – Clinical Supply Quality

60 000 - 96 255
Формат работы
hybrid
Тип работы
fulltime
Английский
b2
Страна
Belgium
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

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TL;DR
Quality Assurance Associate – Clinical Supply Quality (Clinical Trials/MedTech): Investigating clinical product quality complaints and logistics-related quality issues for investigational medicines with an accent on risk assessment, root-cause analysis, compliance, and cross-functional quality oversight. Focus on coordinating investigations, implementing CAPAs, managing clinical supply risks, and improving quality processes across global clinical development and manufacturing operations.

Location: Hybrid role in Beerse, Antwerp, Belgium

Base pay: €60,000–€96,255 per year, plus an annual bonus and benefits.

Company

Johnson & Johnson MedTech develops healthcare solutions and innovative therapies, including investigational medicines and advanced therapy products.

What you will do

  • Investigate clinical product quality complaints and logistics-related quality issues involving investigational medicines.
  • Coordinate cross-functional investigations, identify root causes, assess risks, and define appropriate actions.
  • Evaluate potential impacts on product quality, patient safety, and clinical trial continuity.
  • Support corrective and preventive actions, escalation, follow-up, and timely issue resolution.
  • Represent Quality in review meetings, global projects, and compliance initiatives.
  • Partner with Clinical Development, Manufacturing, Supply Chain, logistics providers, and external manufacturers to improve clinical supply quality.

Requirements

  • University degree in Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, or another relevant scientific discipline.
  • Strong analytical, problem-solving, communication, and stakeholder engagement skills.
  • Ability to work independently, manage complexity, prioritize effectively, assess risks, and own deliverables.
  • Experience in Quality Assurance, GMP-regulated environments, pharmaceutical manufacturing, or pharmaceutical supply chain operations is preferred.
  • Knowledge of global cGMP requirements, ICH guidelines, and quality systems is preferred.
  • Qualified Person certification, Industrial Pharmacist qualification, audit or inspection experience, and understanding of responsible AI practices are advantageous.

Culture & Benefits

  • Collaborative and inclusive environment focused on learning, innovation, and professional development.
  • Exposure to global Quality, R&D, Supply Chain, Manufacturing, and Clinical Development functions.
  • Opportunities to build expertise in investigations, risk management, complaint handling, clinical supply quality, and advanced therapies.
  • Vacation, parental, bereavement, caregiver, and volunteer leave.
  • Well-being reimbursement, financial, physical and mental health programs, insurance plans, and recognition awards.

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