Mgr Quality Systems Data Integrity & Validation

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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 standards.

Support inspection readiness for computerized systems and validation topics.

System Improvements and Digitalisation Initiatives

Lead or provide Quality oversight for system-related improvement initiatives, process optimization, automation, and digitalisation projects.

Ensure digital solutions and system improvements are implemented with appropriate Quality oversight, compliance assessment, validation, change control, and risk management.

Partner with technical, automation, IT, operations, QC, QA, and business stakeholders to ensure digital initiatives are fit for purpose and compliant with GxP expectations.

Drive continuous improvement of Quality Systems, validation processes, Data Integrity controls, and computerized system governance.

Support modernization initiatives while ensuring regulatory compliance, data lifecycle control, and sustainable ownership models.

Promote efficient, compliant, and pragmatic solutions that balance business needs, patient safety, product quality, and regulatory expectations.

Compliance, Governance, and Inspection Readiness

Maintain strong awareness of current and emerging regulatory expectations related to Data Integrity, computerized systems, validation, digitalisation, and Quality Systems.

Ensure local processes remain aligned with applicable internal standards, global procedures, and external regulations.

Support gap assessments against new or updated regulatory requirements, including Annex 11 expectations and related digital compliance requirements.

Act as Quality subject matter expert during regulatory inspections, audits, and internal assessments for Data Integrity, validation, and computerized systems topics.

Ensure inspection preparation materials, storyboards, evidence packages, and remediation plans are accurate, complete, and inspection-ready.

Monitor Quality System performance, identify trends, and drive actions to improve compliance and effectiveness.

Leadership and Stakeholder Management

Provide leadership, coaching, and technical guidance to Quality, business, and technical stakeholders.

Influence cross-functional teams to ensure compliant execution of Data Integrity, validation, and system improvement activities.

Build strong partnerships with QA, QC, Operations, Engineering, Automation, IT, Validation, and global Quality functions.

Communicate complex technical and compliance topics clearly to different levels of the organization, including senior management.

Ensure priorities, risks, resource needs, and compliance concerns are clearly escalated and followed through to resolution.

Foster a culture of Quality, compliance, continuous improvement, accountability, and inspection readiness.

Required Qualifications and Experience

Bachelor’s or Master’s degree in a scientific, pharmaceutical, engineering, 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.

Demonstrated experience with Data Integrity requirements, data governance, audit trail review, data lifecycle management, and computerized systems controls.

Strong technical and QA systems background, with the ability to understand system architecture, data flows, validation strategies, access controls, interfaces, backup/restore, and system lifecycle controls.

Knowledge of applicable regulatory requirements and industry guidance, including EU GMP Annex 11, 21 CFR Part 11, GAMP 5, GMP requirements, and Quality Risk Management principles.

Experience with validation lifecycle management for GxP computerized systems, laboratory systems, manufacturing systems, automation systems, or digital platforms.

Experience leading or supporting system improvements, digitalisation initiatives, remediation programs, or cross-functional compliance projects.

Experience supporting regulatory inspections, internal audits, gap assessments, and inspection readiness activities.

Fluent knowledge of English language.

Strong Quality and compliance mindset.

Excellent understanding of Data Integrity and computerized systems compliance.

Strong technical affinity and ability to translate technical system topics into Quality and compliance requirements.

Strong analytical, risk-based, and pragmatic problem-solving skills.

Ability to lead complex cross-functional initiatives and influence without direct authority.

Excellent communication, stakeholder management, and escalation skills.

Ability to manage competing priorities in a dynamic and regulated environment.

Strong documentation, review, and approval skills.

Continuous improvement mindset with the ability to drive sustainable, compliant change.

High level of ownership, accountability, and independent judgment.

Preferred Qualifications

Experience with site-level Data Integrity or Data Governance programs.

Experience with Annex 11 readiness, 21 CFR Part 11 assessments, validation remediation, or computerized system compliance programs.

Experience with digital transformation, automation, AI-enabled systems, electronic Quality Systems, or system modernization initiatives in a GxP environment.

Experience with Quality Risk Management, Lean, Process Excellence, or project management methodologies.

Experience managing, coaching, or mentoring professionals in a Quality or technical environment.

Required Skills:

Quality Management Systems (QMS)

Preferred Skills:

Data Gathering and Analysis, Data Quality, Quality Standards

The anticipated base pay range for this position is:

€68 600,00 - €119 600,00

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.