Quality Assurance Associate – Clinical Supply Quality

Johnson & Johnson Innovative Medicine; Beerse; Sur place; EUR 60 000 - 96 000; Plein temps

Résumé du poste

Johnson & Johnson Innovative Medicine in Beerse, Belgium seeks a Quality Assurance Associate – Clinical Supply Quality (CSQ) to join the CSQ Post-Certification team. You will help ensure the quality, safety, and compliance of investigational medicines used in clinical trials worldwide, working across Quality, Supply Chain, Clinical Development, and Manufacturing.

The role offers exposure to quality investigations, risk management, complaint handling, and CAPAs while collaborating with global

Qualifications

• 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
• Strong communication and stakeholder engagement skills
• Ability to assess risks, develop action plans, and support issue resolution

Responsabilités

• 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
• Every investigation and quality decision contributes to ensuring that patients participating in clinical trials receive safe, compliant, and high-quality investigational medicines.

Connaissances

Quality Assurance

Analytical skills

Problem solving

Independent work

Cross-functional collaboration

Formation

University degree in Pharmaceutical Sciences, Chemistry, Biology, Biotechnology

Description du poste

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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

Every investigation and quality decision contributes to ensuring that patients participating in clinical trials receive safe, compliant, and high-quality investigational medicines.

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

We are looking for someone who combines scientific knowledge, strong analytical skills, and the ability to collaborate effectively across a global organization.

Required Qualifications

• 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
• Strong communication and stakeholder engagement skills
• Ability to assess risks, develop action plans, and support issue resolution

Preferred Qualifications

• Experience in Quality Assurance, GMP-regulated environments, pharmaceutical manufacturing, or pharmaceutical supply chain operations
• Knowledge of global cGMP requirements, ICH guidelines, and quality systems
• Operational Quality and/or Manufacturing experience
• Qualified Person (QP) certification or Industrial Pharmacist qualification is considered an advantage
• Experience participating in audits, inspections, investigations, or continuous improvement initiatives
• Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity

What we offer

We offer a collaborative and inclusive environment where learning, innovation, and professional development are encouraged.

In this role, you will have the opportunity to work across global functions, contribute to the development of innovative therapies, and build expertise in quality, clinical development, and supply chain operations.

Our commitment to inclusion

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation is powered by bringing together people with different backgrounds, experiences, and perspectives.

We are proud to be an equal opportunity employer and welcome applications from qualified candidates of all backgrounds.

If you require a reasonable accommodation during the application, interview, or onboarding process, support is available. Please let us know how we can help.

#SCQuality

The Anticipated Base Pay Range For This Position Is

€60 000,00 - €96 255,00

Benefits

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

• This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.