Mgr Quality Systems Data Integrity & Validation

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: Janssen Biologics (JBV) is recruiting for a Mgr Quality Systems Data Integrity & Validation, reporting to the Sr. Manager Quality Sytems and located 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 i