7 дней назад
Quality Assurance Associate – Clinical Supply Quality
60 000 - 96 255€
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
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.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →