Real-Time QA Lead - GMP Compliance & Manufacturing

Leiden Bio Science Park; Leiden; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being programs

Job summary

Johnson & Johnson Innovative Medicine in Leiden, The Netherlands, seeks a Senior Specialist QA to provide proactive real-time quality assurance within manufacturing operations. You will guide GMP-compliant activities, observe aseptic and critical processes, and support investigations and CAPAs to maintain product quality.

The role requires strong QA experience in a GMP environment, extensive regulatory knowledge, and the ability to make timely quality decisions with independent judgment on the

Qualifications

• Minimum 8 years of experience in a GMP-regulated environment with a Bachelor's degree, or 6 years with a Master's degree
• Experience leading investigations, quality risk assessments, and compliance-related decision-making
• Strong QA experience with a collaborative approach in a fast-paced manufacturing setting

Responsibilities

• Maintain an active QA presence in manufacturing areas during assigned shifts
• Provide real-time quality guidance and oversee GMP compliance
• Support investigations, non-conformances, CAPAs, and change controls
• Review GMP documentation, deviations, and risk assessments
• Contribute to inspections readiness and quality systems improvements

Skills

QA experience

Investigations

Quality risk assessments

Regulatory knowledge (cGMP/ICH/FDA/EMA

Decision making under pressure

Communication and influence

Education

Bachelor's degree in Biotechnology/ Biology/ Life Sciences or related field

8+ years GMP experience or 6+ years with Master's

Tools

SAP quality processes

Job description

Johnson & Johnson Innovative Medicine in Leiden, The Netherlands, seeks a Senior Specialist QA to provide proactive real-time quality assurance within manufacturing operations. You will guide GMP-compliant activities, observe aseptic and critical processes, and support investigations and CAPAs to maintain product quality.

The role requires strong QA experience in a GMP environment, extensive regulatory knowledge, and the ability to make timely quality decisions with independent judgment on the