QA Specialist – Real-Time Plant Quality Lead

Biopharma Careers; Leiden; Remote; EUR 75,000 - 110,000; Full time

Job summary

Johnson & Johnson Innovative Medicine in Leiden, Netherlands seeks an Experienced Specialist, QA to provide real-time quality assurance support on the manufacturing floor. You will strengthen GMP compliance, investigate deviations, and guide operations with independent QA oversight.

The role requires 6+ years in GMP environments, a science degree, and strong collaboration with MSAT, Engineering, and QC teams to ensure product quality and inspection readiness.

Qualifications

• Minimum 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, Manufacturing Operations, Quality Control, or related pharmaceutical functions.
• Experience leading investigations, quality risk assessments, and compliance-related decision-making.

Responsibilities

• Maintain an active QA presence in manufacturing areas during assigned shifts and observe GMP operations.
• Provide real-time quality guidance, support investigations, and manage non-conformances.
• Review GMP documentation, deviations, CAPAs, and change controls; support inspection readiness.
• Collaborate with Operations, MSAT, Engineering, and Quality Control to ensure compliance and continuous improvement.

Skills

Quality Assurance

GMP compliance

Investigations

CAPA

Change control

Risk management

Root cause analysis

MES / SAP

Education

Bachelor’s degree or higher in Biotechnology, Biology, Pharmacy, Chemistry, Life Sciences

Tools

MES

SAP

Job description

Johnson & Johnson Innovative Medicine in Leiden, Netherlands seeks an Experienced Specialist, QA to provide real-time quality assurance support on the manufacturing floor. You will strengthen GMP compliance, investigate deviations, and guide operations with independent QA oversight.

The role requires 6+ years in GMP environments, a science degree, and strong collaboration with MSAT, Engineering, and QC teams to ensure product quality and inspection readiness.