Manager, Quality Systems, Data Integrity & Validation

7266-Janssen Biologics B.V. Legal Entity

Leiden

On-site

EUR 69,000 - 120,000

Full time

6 days ago

Be an early applicant

Application generator

Get a reply from this employer — a resume and cover letter tailored to exactly what they’re hiring for.

Get past ATS filters

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Caregiver leave

Volunteer leave

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson Leiden seeks a Manager for Quality Systems Data Integrity & Validation to oversee Data Integrity and validation in a GxP environment. You will lead governance, risk assessments, and remediation efforts across data, systems, and digital initiatives.

Responsibilities include validation of computerized systems, site data governance, and compliance with EU GMP Annex 11 and 21 CFR Part 11. Strong leadership, English fluency, and cross-functional collaboration are essential.

Qualifications

Extensive experience in Quality Assurance, Quality Systems, or validation within a regulated industry.
Deep understanding of Data Integrity concepts, data governance, and audit trails.
Knowledge of regulatory requirements (EU GMP Annex 11, 21 CFR Part 11, GAMP 5).
Experience with validation lifecycle management for GxP computerized systems and related IT/automation.
Strong leadership, communication, and cross-functional collaboration skills.

Responsibilities

Provide Quality oversight for Data Integrity, governance, and data risk assessments.
Lead validation activities for GxP computerized systems, equipment, and digital tools.
Oversee system improvements, digitalisation initiatives, and risk management.
Support inspection readiness, audits, and regulatory inspections.
Lead and mentor stakeholders across QA, QC, IT, Operations, and Validation teams.