Quality Assurance Associate – Clinical Supply Quality

Il y a 4 jours

Geel, Antwerpen, Belgique 7555-Janssen Pharmaceutica NV Legal Entity Temps plein 60 000 € - 96 000 € Contrat

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Quality Job Sub Function: Quality Assurance Job Category: Professional All Job Posting Locations: Beerse, Antwerp, Belgium

Job Description

We are searching for the best talent for a Quality Assurance Associate – Clinical Supply Quality (CSQ). Purpose We are looking for a Quality Assurance Associate to join the Clinical Supply Quality (CSQ) Post-Certification team. In this role, you will help ensure the quality, safety, and compliance of investigational medicines used in clinical trials around the world. Working across Quality, Supply Chain, Clinical Development, and Manufacturing, you will contribute to the delivery of compliant investigational products and support the development of innovative therapies for patients.

Are you interested in building expertise in quality investigations, clinical supply quality, and complaint management while working across global teams and clinical development programs? The Clinical Supply Quality Post-Certification team provides global quality oversight for clinical supply logistics and owns the clinical complaint handling process for investigational products used in Johnson & Johnson clinical studies. You will be responsible for In this role, you will support the management and investigation of Clinical Product Quality Complaints and logistics-related quality issues. Working with cross-functional partners, you will help ensure quality concerns are investigated effectively, risks are appropriately assessed, and actions are implemented in a timely manner. You will contribute to complaint investigations, quality review activities, and continuous improvement initiatives while helping maintain compliance and supporting the safe supply of investigational medicines used in clinical trials.

Key responsibilities include:

  • Investigating clinical product quality complaints and logistics-related quality issues
  • Coordinating cross-functional investigations to identify root causes and define appropriate actions
  • Assessing the potential impact of events on product quality, patient safety, and clinical trial continuity
  • Supporting implementation and follow-up of corrective and preventive actions (CAPAs)
  • Escalating quality issues when appropriate and ensuring timely resolution of actions
  • Participating in quality review meetings and contributing to quality and compliance initiatives
  • Identifying opportunities to improve processes, strengthen compliance, and enhance operational effectiveness
  • Partnering with Clinical Development, Manufacturing, Supply Chain teams, logistics providers, and external manufacturers
  • Representing Quality in local and global projects, as assigned
  • Building effective relationships with business partners and promoting a quality-focused approach
  • Supporting investigation, complaint handling, risk management, and clinical supply quality processes across the organization

Why this role is exciting

This role provides a unique opportunity to: Influence the quality of investigational medicines used in clinical trials across the globe Build expertise in investigations, risk management, complaint handling, and clinical supply quality Gain visibility across R&D, Supply Chain, Manufacturing, Clinical Development, and Quality Support the development and delivery of innovative medicines, including next-generation therapies and Advanced Therapy Medicinal Products (ATMPs) Participate in process improvement, digitalization, and innovation initiatives Develop a strong foundation for future career opportunities in Quality Leadership, Qualified Person (QP) pathways, R&D Quality, Advanced Therapies, and related areas.

Qualifications / Requirements

  • University degree in Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, or another relevant scientific discipline
  • Strong analytical and problem-solving skills
  • Ability to work independently while collaborating effectively across teams
  • Ability to manage complexity, prioritize effectively, and take ownership of deliverables