QA Specialist, Plant Floor – GMP & Compliance

Johnson & Johnson Innovative Medicine; Leiden; On-site; EUR 54,000 - 85,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Job summary

Johnson & Johnson Innovative Medicine in Leiden, The Netherlands, is seeking an Experienced Specialist, QA – Quality in the Plant. You will provide proactive QA support in manufacturing operations, strengthen GMP compliance, and guide investigations with independent QA judgment.

The role emphasizes real-time quality decisions, cross-functional collaboration, and a strong quality culture across site operations, with a daytime start and eventual 16/7 coverage as the model matures.

Qualifications

• Bachelor’s degree or higher in Biotechnology, Biology, Pharmacy, Chemistry, Life Sciences, or another relevant scientific field
• Minimum 6 years of experience in a GMP-regulated environment with a Bachelor’s degree, or 4 years of experience 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
• Provide real-time quality guidance and first-line QA support for manufacturing questions and events
• Review GMP documentation, investigations, deviations, CAPAs, and change controls within the assigned scope
• Support inspection readiness activities across the site and participate in QA risk assessments
• Build strong collaborative relationships with Operations, MSAT, Engineering, Warehouse, Quality Control, and Training functions

Skills

GMP knowledge

QA oversight

Communication

Problem solving

Education

Bachelor’s degree in Biotechnology/Biology/Chemistry or Life Sciences

Tools

MES

SAP

Job description

Johnson & Johnson Innovative Medicine in Leiden, The Netherlands, is seeking an Experienced Specialist, QA – Quality in the Plant. You will provide proactive QA support in manufacturing operations, strengthen GMP compliance, and guide investigations with independent QA judgment.

The role emphasizes real-time quality decisions, cross-functional collaboration, and a strong quality culture across site operations, with a daytime start and eventual 16/7 coverage as the model matures.