Global Operations Data Integrity Lead

Johnson & Johnson Innovative Medicine; Leiden; On-site; EUR 107,000 - 166,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Well-being reimbursement

Job summary

Johnson & Johnson Innovative Medicine in Leiden, Netherlands seeks a Senior Manager Operations Data Integrity Lead to drive Data Integrity and Governance across Biotherapeutics Operations. You will partner with Quality, Site Compliance, GET/JJT Automation, MSAT, QC, System Owners, and Operations leaders to embed DI expectations into shopfloor processes.

The role reports to the Sr. Director Biotherapeutics Operations with matrix leadership across teams.

Qualifications

• Bachelor’s degree in science, engineering, biotechnology, pharmaceutical sciences, automation, quality, or related discipline; Master’s degree preferred.
• 8+ years of experience in 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.

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

Coaching

Collaboration

Controls Compliance

Fact-Based Decision Making

Financial Competence

ISO 9001

Lean Supply Chain Management

Non-Conformance Reporting

Process Improvements

Quality Control Testing

Quality Standards

Quality Systems Documentation

Quality Validation

STEM Application

Schematic Design

Tactical Planning

Technical Credibility

Education

Bachelor’s degree

Master’s degree preferred

Tools

ALCOA+

Computerized system validation

Job description

Johnson & Johnson Innovative Medicine in Leiden, Netherlands seeks a Senior Manager Operations Data Integrity Lead to drive Data Integrity and Governance across Biotherapeutics Operations. You will partner with Quality, Site Compliance, GET/JJT Automation, MSAT, QC, System Owners, and Operations leaders to embed DI expectations into shopfloor processes.

The role reports to the Sr. Director Biotherapeutics Operations with matrix leadership across teams.