2X QA Release Responsible (DAP)

Johnson & Johnson · Beerse

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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.

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Important Notice

There are currently two vacancies available for this position. We welcome applications from qualified candidates who are interested in joining our team and look forward to hearing from you!

We are searching for the best talent for a QA Release Responsible – Device Assembly & Parenteral Packaging.

Purpose

We are looking for a QA Release Responsible to join the Quality organization at Johnson & Johnson Innovative Medicine in Beerse, Belgium.

Do you enjoy working in a dynamic pharmaceutical manufacturing environment while helping ensure products meet the highest quality and compliance standards?

The Quality Department 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 support for Device Assembly and Parenteral Packaging operations, including batch release activities, quality oversight of manufacturing processes, investigation management, and inspection readiness activities.

You will work closely with Operations, Quality, and cross-functional partners to help ensure compliance with GMP requirements, marketing authorizations, and internal quality standards.

You will be responsible for

In this role, you will provide Quality oversight for Device Assembly and Parenteral Packaging activities and support day-to-day quality operations within the area.

Key responsibilities include:

• Releasing incoming half-finished products and assembled/finished products in a timely manner
• Reviewing and supporting investigations, deviations, CAPAs, Change Controls, and trend reports to help ensure issues are appropriately assessed and addressed
• Providing Quality and compliance expertise during investigations and issue resolution activities
• Ensuring compliance with applicable GMP requirements and marketing authorizations
• Acting as a Quality spokesperson during Health Authority inspections, internal audits, and customer audits
• Performing check rounds and periodic witnessing of operational processes
• Establishing and maintaining effective working relationships with Business and Quality partners and serving as a Quality point of contact
• Supporting quality oversight of operational activities through review and approval of GMP documentation
• Representing Quality on projects and helping ensure alignment with applicable quality and compliance requirements
• Ensuring events with potential impact on patient safety, product quality, and/or product supply are appropriately escalated

The role contributes to maintaining inspection readiness, supporting compliant operations, and helping ensure quality is embedded in manufacturing activities.

Qualifications / Requirements

We are looking for someone who combines strong quality and GMP knowledge with the ability to collaborate effectively across a manufacturing environment.

Education

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

Experience

• 2–5 years of experience within the pharmaceutical industry

Knowledge & Skills

• Familiarity with GMP requirements and pharmaceutical manufacturing environments
• Fluent Dutch and English, both spoken and written
• Ability to communicate effectively with manufacturing, quality, and cross-functional stakeholders in a bilingual environment
• Strong quality-focused approach with attention to detail and accuracy
• Ability to work independently while maintaining strong connections with key stakeholders
• Ability to work effectively within cross-functional teams and maintain constructive working relationships
• Ability to manage competing priorities and perform effectively under time constraints
• Ability to make risk-based decisions in a dynamic environment
• Familiarity with risk management principles
• Strong analytical and problem-solving skills
• Continuous improvement approach
• Knowledge of pharmaceutical legislation, cGMP regulations, ICH guidelines, policies, and procedures
• Strong communication and networking skills
• Ability to understand business implications of quality-related decisions and positions
• 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 closely with manufacturing and quality teams, support products that make a meaningful difference for patients, and contribute to the ongoing evolution of quality within pharmaceutical 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.

#LI-Hybrid

#SCQuality

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