Pharma QA Specialist: cGMP & Regulatory Readiness (Leiden)

jj

Leiden

On-site

EUR 45,000 - 71,000

Full time

13 days ago

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Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Caregiver leave

Well-being reimbursement

Service anniversary awards

Job summary

Johnson & Johnson Innovative Medicine Biologics Leiden seeks a Quality Assurance Specialist to ensure site compliance with cGMP and to drive CAPA implementations. You will support regulatory inspections and collaborate with cross-functional teams to maintain product quality and patient safety. Fluency in Dutch and English is required.

The role involves reviewing change controls, leading investigations, and advancing continuous improvement within the QA-OCP team in Leiden.

Qualifications

Bachelor’s degree in bioscience, chemistry, or pharmacy with 4–6 years’ experience, OR Master’s with 2–4 years’ experience.
Preferable experience in Quality Assurance within pharma or related field.
Experience leading quality investigations, root cause analysis, and CAPAs.
Up-to-date knowledge of cGMP and regulatory expectations.
Strong communication in Dutch and English, both written and spoken.
Familiarity with process improvement methods like LEAN.

Responsibilities

Provide timely cGMP and quality advice to maintain compliance during operations.
Lead end-to-end site investigations and CAPA implementations.
Support regulatory inspections and audit readiness.
Review and approve change controls for production and QC testing.
Evaluate study and validation protocols to ensure controlled studies.
Collaborate on quality risk management and root-cause analysis.