Quality Systems Leader: Data Integrity & Validation

Johnson & Johnson Innovative Medicine; Leiden; On-site; EUR 69,000 - 120,000; Full time

Job summary

Johnson & Johnson Innovative Medicine in Leiden, Netherlands, seeks a Manager Quality Systems Data Integrity & Validation to lead data governance, validation lifecycle, and computerized systems compliance in a GxP environment. Reporting to the Sr.

Manager Quality Systems, you will drive regulatory readiness, risk-based decision making, and cross-functional collaboration to ensure data integrity and system modernization across QA functions.

Qualifications

• Bachelor’s or Master’s degree in scientific, pharmaceutical, quality, automation, IT, or related discipline.
• Significant experience in the pharmaceutical, biotechnology, medical device, or other regulated GxP industry.
• Strong experience in Quality Assurance, Quality Systems, computerized systems validation, Data Integrity, compliance, or related technical Quality functions.
• Fluent knowledge of English language.

Responsibilities

• Quality oversight of Data Integrity, Data Governance, and related programs across GxP processes and computerized systems.
• Provide validation oversight for lifecycle activities, risk assessments, and validation plans and reports.
• Ensure systems remain in a validated state and aligned with regulatory expectations (EU GMP Annex 11, 21 CFR Part 11, GAMP 5).
• Support inspection readiness and regulatory inspections with accurate evidence.

Skills

QMS

Data Integrity

Validation

GxP Knowledge

Education

Bachelor’s or Master’s degree in a related field

Job description

Johnson & Johnson Innovative Medicine in Leiden, Netherlands, seeks a Manager Quality Systems Data Integrity & Validation to lead data governance, validation lifecycle, and computerized systems compliance in a GxP environment. Reporting to the Sr.

Manager Quality Systems, you will drive regulatory readiness, risk-based decision making, and cross-functional collaboration to ensure data integrity and system modernization across QA functions.