The Specialist Quality Assurance acts as a quality expert supporting the implementation and execution of Quality Systems to enable the successful introduction and manufacture of new biotherapeutic products. The role ensures compliance with cGMP, global regulatory requirements, and company policies by working cross‑functionally with Operations, QC, Engineering, Planning, and Development. Through independent judgment and subject‑matter expertise, the Specialist QA contributes to a strong quality culture while enabling the consistent delivery of safe, compliant, and high‑quality products.

Key Responsibilities:

• Implement and maintain Quality Systems including validation, change control, batch record review, and batch release for new and existing products

• Review, prepare, and approve GMP documentation such as validation reviews, method transfer protocols, MES master batch records, material master changes, and change controls
• Perform batch record review and prepare release documentation for raw materials, intermediates, and bulk products
• Act as deputy process owner and subject matter expert for raw material release and WCB/DS/DPC release processes
• Ensure quality systems are compliant, effective, and continuously optimized across the organization
• Serve as a QA representative and subject matter expert during internal and external audits and regulatory inspections
• Deputize for the QA Manager as required, including approval of QA documentation and oversight of key quality processes

Requirements:

• Bachelor’s degree or higher in Biochemistry, Biology, Pharmacy, or a related scientific discipline
• Minimum of 2 years (MSc) or 4 years (BSc) experience in Quality or regulated supply chain operations
• Strong knowledge of biotechnological or pharmaceutical manufacturing and global regulatory guidelines (cGMP, ICH, FDA, EMA)
• Proven analytical, problem‑solving, and risk‑based decision‑making skills with high attention to detail
• Ability to work independently, prioritize effectively, and manage complex or conflicting stakeholder requirements
• Strong communication, influence, and collaboration skills in cross‑functional environments
• Fluent in written and spoken English; knowledge of Dutch and experience in vaccines are considered a plus

At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.