QA New Product Introduction Responsible

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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 QA Specialist – New Product Introduction (NPI).

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