Senior Manager, Data Integrity & Operations

7266-Janssen Biologics B.V. Legal Entity; Amsterdam; On-site; EUR 83,000 - 144,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson is seeking a Senior Manager Operations Data Integrity Lead to drive the Data Integrity and Data Governance framework for Biotherapeutics Operations, translating global requirements into practical standards and governance routines.

The role reports to senior leadership and partners with Quality, Site Compliance, GET/JJT Automation, MSAT, QC, System Owners, and Operations leaders to embed DI expectations into shopfloor activities and support-process workflows.

Qualifications

• Bachelor’s degree in science, engineering, biotechnology, pharmaceutical sciences, automation, quality, or a related discipline; Master’s degree preferred.
• 8+ years of GMP-regulated manufacturing, operations, quality, automation, validation, compliance, or data integrity within biopharmaceuticals or pharmaceuticals.
• Strong working knowledge of EU GMP/EudraLex, Annex 11, FDA expectations, 21 CFR Part 11 principles, ALCOA+, data lifecycle management, and computerized system controls.
• Experience with deviations/NCs, CAPA, change control, audit/inspection readiness, quality risk management, validation, and batch release support.
• Ability to translate compliance gaps into operational actions, governance routines, interim controls, and sustainable remediation plans.
• Proven ability to lead cross-functional teams without formal authority and influence senior stakeholders in a complex manufacturing environment.

Responsibilities

• Own and drive the Operations Compliance Programme.
• Act as SPOC for Operations Compliance, partnering with Quality, IMRC and Operations leadership.
• Drive compliance ownership, documentation discipline, escalation practices and compliance culture across Operations.
• Execute the Site Quality Plan, ensuring actions are prioritized, resourced and delivered.
• Provide a clear compliance narrative to Leadership Teams, including status, trends, risks and required decisions.
• Lead inspection readiness and regulatory response.
• Maintain continuous inspection readiness by identifying compliance vulnerabilities and ensuring timely remediation.
• Coordinate internal and external inspections, including readiness assessments, interview preparation, evidence management and inspection logistics.
• Own inspection responses from observation through closure, ensuring robust root cause analysis, commitments and sustainable CAPAs.
• Translate regulatory requirements into operational strategy and continuous improvement.
• Convert regulatory expectations and compliance gaps into operational priorities, roadmaps, projects and measurable outcomes.
• Anticipate evolving regulatory requirements and incorporate them into a multi-year compliance strategy.
• Sponsor and drive strategic compliance initiatives to strengthen systems, processes, facilities and quality performance.
• Drive risk-based decision making and governance.
• Identify, assess and communicate compliance risks, recommending effective mitigations.
• Facilitate cross-functional prioritization, resource allocation and risk acceptance decisions.
• Establish governance, escalation pathways, KPIs, dashboards and maturity metrics to drive accountability, transparency and sustained improvements.
• Challenge root cause analyses and ensure corrective actions address systemic issues.

Skills

GMP knowledge

Data integrity

Regulatory compliance

Quality systems

Cross-functional leadership

Quality assurance

Risk management

Education

Bachelor’s degree in science/engineering/related discipline

Master’s degree preferred

Job description

Johnson & Johnson is seeking a Senior Manager Operations Data Integrity Lead to drive the Data Integrity and Data Governance framework for Biotherapeutics Operations, translating global requirements into practical standards and governance routines.

The role reports to senior leadership and partners with Quality, Site Compliance, GET/JJT Automation, MSAT, QC, System Owners, and Operations leaders to embed DI expectations into shopfloor activities and support-process workflows.