QA Release 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 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

• 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