Experienced Specialist QA

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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 .

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We provide an inclusive work environment where each person is considered as an individual.

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Job Function:
Quality

Job Sub Function:
Quality Assurance

Job Category:
Professional

All Job Posting Locations:
Leiden, South Holland, Netherlands

Job Description:
e are searching for the best talent for an Experienced QA Specialist.

Purpose

We are looking for an Experienced QA Specialist to join the Quality Assurance team at Johnson & Johnson Innovative Medicine Biologics in Leiden, the Netherlands.

Are you interested in helping strengthen GMP compliance, product quality, and operational excellence within a dynamic pharmaceutical manufacturing environment?

The Quality Assurance department ensures that quality systems are applied in accordance with GMP requirements and supports activities such as non-conformance management, product release, change control, and compliance oversight.

The team plays an important role in providing quality guidance across the supply chain and supporting the reliable delivery of products to patients.

In this role, you will support quality investigations, quality risk management activities, inspection readiness, and compliance initiatives while working closely with cross-functional partners across the site.

You will be responsible for

Working closely with Operations, Quality Control, Manufacturing, and other site functions, you will provide quality guidance on cGMP and quality-related topics arising during routine and non-routine operations.

The role includes participation in investigations, risk management activities, inspection readiness initiatives, and change management processes, while helping ensure compliance with company standards and regulatory requirements.

Key responsibilities include:


* Providing timely and practical quality guidance on cGMP and quality-related topics


* Leading and supporting site investigations and helping ensure corrective and preventive actions (CAPAs) are implemented effectively within agreed timelines


* Supporting preparation activities for regulatory inspections, including FDA and EMA inspections


* Reviewing, assessing, and approving deviation-related change controls


* Partnering with site colleagues to help ensure projects and changes are e...