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Purpose

We are looking for a QA Specialist – New Product Introduction (NPI) to join the Quality organization at Johnson & Johnson Innovative Medicine in Beerse, Belgium.

Are you interested in helping bring new products to market while ensuring quality and compliance are embedded from the start?

The Quality Department at the Johnson & Johnson Innovative Medicine Supply Chain Beerse site supports all GMP activities related to manufacturing, packaging, labeling, testing, release, and distribution of products manufactured on the Belgium campus.

In this role, you will provide Quality Assurance oversight for New Product Introductions (NPI), product transfers, and implementation projects within the Device Assembly and Parenteral Packaging area. Working closely with Manufacturing, Technical Operations, Engineering, Validation, Regulatory Affairs, Supply Chain, and Quality teams, you will help ensure new products and processes are introduced in compliance with GMP requirements, quality standards, and regulatory expectations.

You will be responsible for

In this role, responsibilities include providing Quality Assurance oversight for New Product Introductions, product transfers, and implementation projects within Device Assembly and Parenteral Packaging. The position contributes to risk management, investigation activities, change management, documentation review, inspection readiness, and project execution while supporting successful product launches and commercial manufacturing readiness.

Key responsibilities include:

• Acting as the QA representative and key quality contact for New Product Introduction, product transfer, and implementation projects
• Providing oversight throughout the NPI lifecycle and helping ensure alignment with GMP requirements, the Quality Management System, and applicable regulatory requirements
• Ensuring quality requirements are incorporated into project plans, processes, and deliverables from an early stage
• Providing QA input into the design, development, and implementation of new or modified manufacturing and packaging processes, equipment, and technologies
• Reviewing and approving GMP documentation, including risk assessments, protocols, reports, procedures, and other project-related documentation
• Applying Quality Risk Management principles throughout projects and helping ensure identified product quality, patient safety, and compliance risks are appropriately mitigated
• Providing quality and compliance expertise for deviations, CAPAs, and Change Controls while helping ensure appropriate investigation and timely resolution
• Assessing the impact of project changes on product quality, validated state, regulatory requirements, and GMP compliance
• Supporting the transfer of new products and processes into operations and helping ensure a robust transition from project phase to routine commercial manufacturing
• Supporting and representing Quality during Health Authority inspections, internal audits, and customer audits
• Driving continuous improvement and lessons-learned activities across NPI programs
• Ensuring timely QA release of NPI batches to support launch and market supply objectives
• Providing QA oversight through routine shop floor walkthroughs and witnessing of critical operational activities

Qualifications / Requirements

We are looking for someone who combines strong GMP and Quality knowledge with the ability to work effectively across project teams and manufacturing environments.

Education

• University degree in Pharmaceutical Sciences, Chemical Sciences, Biological Sciences, Engineering, or another relevant scientific discipline

Experience

• Minimum 2–5 years of experience within the pharmaceutical industry

Knowledge & Skills

• Experience working in GMP-regulated pharmaceutical manufacturing environments
• Strong quality-focused mindset with attention to detail and accuracy
• Experience working independently while maintaining strong stakeholder engagement
• Experience working across cross-functional teams and project environments
• Experience making risk-based decisions in a dynamic and fast-paced environment
• Familiarity with Quality Risk Management principles
• Strong analytical and problem-solving skills
• Continuous improvement mindset
• Knowledge of pharmaceutical legislation, cGMP regulations, ICH guidelines, policies, and procedures
• Strong communication, influencing, and networking skills
• Understanding of the business implications of quality-related decisions
• Fluent Dutch and English, both written and spoken
• 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 environment where learning, innovation, and professional development are encouraged.

In this role, you will have the opportunity to work across manufacturing, quality, engineering, validation, and regulatory functions while supporting the introduction of new products that help improve patients' lives.

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.