Senior Manager Operations Data Integrity Lead

Location: Leiden, South Holland, Netherlands

Salary: €82,900–€144,210 annually. Additional Netherlands range: €106,590–€166,000.

Company

Johnson & Johnson MedTech develops healthcare and medical technology solutions across the spectrum of patient care.

What you will do

• Drive the Operations Data Integrity and Data Governance framework for biotherapeutics operations.
• Own the Operations Compliance Programme, including the Site Quality Plan, compliance narrative, documentation discipline, and escalation practices.
• Lead inspection readiness, coordinate internal and external inspections, and manage responses, root cause analysis, commitments, and CAPAs through closure.
• Translate regulatory expectations and compliance gaps into operational priorities, roadmaps, strategic initiatives, and measurable outcomes.
• Establish governance routines, escalation pathways, KPIs, dashboards, and maturity metrics for sustained improvement.
• Provide matrix leadership to system owners, SMEs, project leads, and mapping teams while partnering with Quality, Compliance, Automation, MSAT, QC, and Operations.

Requirements

• Bachelor’s degree in science, engineering, biotechnology, pharmaceutical sciences, automation, quality, or a related discipline; a Master’s degree is preferred.
• At least 8 years of experience in GMP-regulated manufacturing, operations, quality, automation, validation, compliance, or data integrity within biopharmaceuticals or pharmaceuticals.
• Strong 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 and non-conformances, CAPA, change control, audits and inspections, quality risk management, validation, and batch release support.
• Ability to lead cross-functional teams without formal authority and influence senior stakeholders in complex manufacturing environments.
• Strong written and verbal communication skills for creating clear, concise, and defensible leadership and inspection narratives.

Nice to have

• Coaching, collaboration, fact-based decision making, and technical credibility.
• ISO 9001, Lean Supply Chain Management, process improvement, quality control testing, quality validation, and quality systems documentation.

Culture & Benefits

• Annual bonus with a target based on pay grade and location, subject to individual and company performance.
• Vacation days, parental leave of at least 12 weeks, bereavement leave, caregiver leave, and volunteer leave.
• Well-being reimbursement and financial, physical, and mental health programs.
• Service anniversary and recognition awards.
• Eligibility for several insurance plans may extend to dependents in some locations.