Senior Ops Data Integrity & Compliance Leader

Johnson & Johnson Innovative Medicine; Leiden; On-site; EUR 83,000 - 144,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave (12 weeks)

Well-being reimbursement

Job summary

Johnson & Johnson Innovative Medicine in Leiden, Netherlands, seeks a Senior Manager Operations Data Integrity Lead to drive data governance and compliance across Biotherapeutics Operations. You will lead a matrix of Quality, Site Compliance, and Operations teams to embed DI controls on the shop floor and support processes, with audit readiness as a key measure.

The role reports to the Sr. Director Biotherapeutics Operations and collaborates with various SMEs to translate global requirements

Qualifications

• Bachelor’s degree in science, engineering, biotechnology, pharmaceutical sciences, automation, quality, or a related discipline; Master’s degree preferred.
• 8+ years of experience in GMP-regulated manufacturing, operations, quality, automation, validation, compliance, or data integrity.
• Strong working knowledge of EU GMP/EudraLex, Annex 11, FDA expectations, 21 CFR Part 11 principles, ALCOA+, data lifecycle management, and computerized system controls.

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.
• 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.

Skills

Data Integrity

Regulatory Compliance

Cross-functional Leadership

Quality Systems

Stakeholder Influence

Education

Bachelor’s degree in science

Master’s degree preferred

Job description

Johnson & Johnson Innovative Medicine in Leiden, Netherlands, seeks a Senior Manager Operations Data Integrity Lead to drive data governance and compliance across Biotherapeutics Operations. You will lead a matrix of Quality, Site Compliance, and Operations teams to embed DI controls on the shop floor and support processes, with audit readiness as a key measure.

The role reports to the Sr. Director Biotherapeutics Operations and collaborates with various SMEs to translate global requirements