Senior QA Specialist, Advanced Therapies (GMP)

7266-Janssen Biologics B.V. Legal Entity; Sassenheim; On-site; EUR 54,000 - 85,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being reimbursement

Job summary

Johnson & Johnson is seeking an Experienced Specialist, QA to join the Advanced Therapies Quality Assurance team at the Leiden/Sassenheim site in the Netherlands. This role focuses on strengthening GMP compliance, quality oversight, and inspection readiness across commercial and clinical manufacturing activities.

You will partner with Operations, QC, and MSAT to ensure product supply while maintaining high quality standards and facilitating regulatory compliance.

Qualifications

• Bachelor's degree or higher in Biochemistry, Biology, Pharmaceutical Sciences, or another relevant scientific field.
• 6+ years of experience in a GMP-regulated environment with a Bachelor's degree, or 4+ years with a Master's degree.
• Experience in Quality Assurance, Quality Control, manufacturing operations, or related pharmaceutical/biotech environments.
• Knowledge of GMP regulations (FDA/EMA) and ICH guidelines.

Responsibilities

• Provide QA oversight for Advanced Therapies production activities.
• Provide quality guidance for GMP processes including Change Control & Document Control.
• Support inspection readiness and regulatory inspections.
• Review investigations and monitor root cause analyses.
• Coordinate GMP training and CAPA management.
• Escalate GMP issues and support global quality initiatives.
• Participate in Quality Risk Management activities.

Skills

Independent work

Analytical thinking

Communication skills

Decision making

Collaboration

English fluency

Quality mindset

Education

Bachelor's degree or higher in Biochemistry, Biology, Pharmaceutical Sciences

Job description

Johnson & Johnson is seeking an Experienced Specialist, QA to join the Advanced Therapies Quality Assurance team at the Leiden/Sassenheim site in the Netherlands. This role focuses on strengthening GMP compliance, quality oversight, and inspection readiness across commercial and clinical manufacturing activities.

You will partner with Operations, QC, and MSAT to ensure product supply while maintaining high quality standards and facilitating regulatory compliance.