Mgr Quality Systems Data Integrity & Validation

Johnson Johnson; Leiden; On-site; EUR 110,000 - 160,000; Full time

Job summary

Johnson & Johnson in Leiden, Netherlands seeks a Manager Quality Systems Data Integrity & Validation to lead Data Integrity, Validation and computerized systems compliance within BioTherapeutics Quality Systems and Compliance. The role requires strong judgment to translate regulatory expectations into practical Quality System requirements and drive improvements with cross-functional teams.

The position focuses on data governance, validation lifecycle management, and digital transformation in a

Qualifications

• Experience in Data Integrity, Validation and computerized systems compliance.
• Ability to interpret regulatory expectations into Quality System requirements.
• Experience in a complex GxP environment with inspection readiness.

Responsibilities

• Oversee Data Integrity program and governance.
• Lead Data Integrity risk assessments, audits, remediation.
• Provide validation oversight for GxP computerized systems.
• Ensure lifecycle validation documents are compliant and up to date.
• Partner with cross-functional teams to implement improvements.

Skills

Quality Oversight

Data Integrity

Validation

GxP Compliance

Regulatory Knowledge

Cross-functional Collaboration

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Quality

Job Sub Function: Quality Systems

Job Category: People Leader

All Job Posting Locations: Leiden, Netherlands

Job Description:

We are looking for a Manager Quality Systems Data Integrity & Validation to join our BioTherapeutics Quality Systems and Compliance team in Leiden, The Netherlands .

Primary focus

Quality oversight of Data Integrity, Validation, computerized systems compliance, system-related improvements, and digitalisation initiatives in a GxP environment.

Scope and Complexity

This role operates in a complex, highly regulated, multi-functional GxP environment. The Manager Quality Systems must be able to interpret regulatory expectations, translate them into practical Quality System requirements, and drive compliant execution across technical and operational teams. The role requires strong judgment, independent decision-making, and the ability to balance regulatory compliance, technical feasibility, business priorities, and patient safety. The position has a significant impact on site inspection readiness, computerized systems compliance, Data Integrity maturity, and the successful implementation of digital and system improvement initiatives.

Role Purpose

The Manager Quality Systems is responsible for providing Quality oversight and leadership for Data Integrity, Validation, computerized systems compliance, and related Quality System improvements. The role ensures that GxP systems, processes, and data governance activities are designed, implemented, maintained, and improved in compliance with applicable regulatory requirements, company standards, and industry expectations. The position plays a key role in strengthening site compliance, inspection readiness, and the maturity of Quality Systems related to computerized systems, Data Integrity, validation lifecycle management, and digital transformation. The Manager acts as a Quality subject matter expert and business partner for cross-functional teams, ensuring that technical, operational, and digital initiatives are implemented in a compliant, risk-based, and sustainable manner.

Principal Responsibilities

Quality Oversight of Data Integrity

• Provide Quality oversight for the site Data Integrity and Data Governance program.
• Ensure Data Integrity principles are embedded in the Quality Management System and applied consistently across GxP processes and computerized systems.
• Provide Quality leadership for Data Integrity assessments, data risk assessments, data process flow mapping, audit trail review strategies, and remediation plans.
• Ensure appropriate controls are defined, implemented, verified, and maintained to support the reliability, completeness, accuracy, and traceability of GxP data.
• Support the identification, prioritization, escalation, and remediation of Data Integrity risks and gaps.
• Provide guidance on Data Integrity requirements during deviations, CAPAs, change controls, periodic reviews, system upgrades, system retirement, and inspection preparation.
• Ensure timely communication and escalation of significant Data Integrity risks to senior management.

Quality Oversight of Validation and Computerized Systems

• Provide Quality oversight for validation activities related to GxP computerized systems, equipment, instruments, digital tools, and associated business processes.
• Ensure validation deliverables are compliant, scientifically sound, risk-based, and aligned with intended use.
• Review and approve key validation lifecycle documents, including compliance assessments, user requirements, risk assessments, validation plans, test strategies, validation reports, periodic reviews, and retirement documentation.
• Ensure computerized systems remain in a validated and controlled state throughout their lifecycle.
• Provide Quality input into system categorization, validation strategy, audit trail requirements, access controls, backup and restore requirements, data migration, interfaces, system security, and archival strategies.
• Ensure validation and computerized system processes are aligned with applicable regulations and expectations, including EU GMP Annex 11, 21 CFR Part 11, GAMP 5 principles, and internal company s