Quality Assurance Associate – Clinical Supply Quality

7555-Janssen Pharmaceutica NV Legal Entity; Geel; Hybride; EUR 60 000 - 96 000; Plein temps

Avantages offerts par ce poste

Vacation days

Parental leave

Bereavement leave

Caregiver leave

Volunteer leave

Well-being reimbursement

Insurance plans

Résumé du poste

Johnson & Johnson in Belgium seeks a Quality Assurance Associate – Clinical Supply Quality (CSQ) to join the CSQ Post-Certification team, ensuring compliant investigational medicines used in clinical trials worldwide.

You will work across Quality, Supply Chain, Clinical Development, and Manufacturing to manage investigations, risk assessments, CAPAs, and issue resolution, promoting strong quality and patient safety across programs.

Qualifications

• University degree in Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, or related scientific discipline.
• Strong analytical and problem-solving skills.
• Ability to work independently while collaborating effectively across teams.
• Strong communication and stakeholder engagement skills.
• Experience in Quality Assurance, GMP-regulated environments is preferred.
• Knowledge of global cGMP requirements and ICH guidelines is preferred.

Responsabilités

• Investigating clinical product quality complaints and logistics-related quality issues.
• Coordinating cross-functional investigations to identify root causes and 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.

Connaissances

Analytical skills

Independent work

Team collaboration

Communication skills

Risk assessment

Action planning

Issue resolution

Formation

University degree in Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, or related discipline

Description du poste

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
• 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.

Benefits

• Annual salary based on the pay grade, location, and individual performance
• Target bonus based on pay grade/location (percentage of pay)
• Sales commissions
• Vacation days
• Parental leave (minimum of 12 weeks)
• Bereavement leave
• Caregiver leave
• Volunteer leave
• Well-being reimbursement
• Programs for financial, physical and mental health
• Service anniversary and recognition awards
• Eligibility to participate in several insurance plans (employee and eligible dependents)

Anticipated base pay range: €60 000,00 - €96 255,00

#LI-Hybrid #SCQuality