QA Specialist — GMP Compliance & Batch Release

Johnson & Johnson Innovative Medicine; Leiden; On-site; EUR 38,000 - 61,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Job summary

Johnson & Johnson Innovative Medicine in Leiden, Netherlands, seeks an Associate Specialist QA to ensure GMP compliance during product introduction and lifecycle in the manufacturing environment.

You will collaborate with Operations, Quality Control, Engineering, and Development to support quality systems, documentation, and change control, driving continuous improvement and a strong quality culture.

Qualifications

• Bachelor’s degree or higher in Biochemistry, Biology, Pharmacy, Life Sciences, or related field.
• Minimum of 2 years of experience in a GMP-regulated environment within QA, QC, Manufacturing, or related pharma/biotech function.
• Strong understanding of GMP regulations, quality systems, batch release processes, change control, and compliance requirements.
• Experience in biotech/pharma; knowledge of gene therapy and biological products is a plus.
• Excellent analytical, problem-solving, and decision-making skills with attention to detail and ability to work independently.
• Strong communication and stakeholder management with English proficiency; Dutch a plus.

Responsibilities

• Perform electronic batch record reviews and support batch disposition activities per GMP requirements.
• Review and release raw materials while maintaining quality systems master data.
• Assess, approve, and verify change controls for compliant implementation.
• Review and approve GMP documents including master batch records and validation reviews.
• Prepare release packages for Qualified Persons (QP) and support product release processes.
• Participate in local/global quality projects and promote quality culture across the organization.

Skills

GMP knowledge

Analytical thinking

Problem solving

Attention to detail

Independent work

Communication

Education

Bachelor’s degree or higher in Biochemistry, Biology, Pharmacy, Life Sciences, or related

Job description

Johnson & Johnson Innovative Medicine in Leiden, Netherlands, seeks an Associate Specialist QA to ensure GMP compliance during product introduction and lifecycle in the manufacturing environment.

You will collaborate with Operations, Quality Control, Engineering, and Development to support quality systems, documentation, and change control, driving continuous improvement and a strong quality culture.