Senior Manager, Data Integrity & Operations Compliance

Biopharma Careers; Leiden; On-site; EUR 83,000 - 144,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Bereavement leave

Caregiver leave

Volunteer leave

Well-being reimbursement

Benefits programs

Job summary

Johnson & Johnson’s Leiden site seeks a Senior Manager Operations Data Integrity Lead to drive the Data Integrity and Data Governance framework across Biotherapeutics Operations. You will translate global requirements into practical standards and measurable improvements, partnering with Quality, Site Compliance, and Operations leaders to embed DI in shopfloor routines.

You will lead matrix teams, own the DI program, and ensure robust governance, audits, and CAPA outcomes while guiding risk-based

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.
• 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.
• Strong written and verbal communication skills with ability to create clear, concise, defensible narratives for leadership and inspections.

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, including readiness assessments and evidence management.

Skills

Data integrity

Data governance

Regulatory compliance

Project leadership

Risk-based decision making

Cross-functional collaboration

Documentation discipline

Inspection readiness

Education

Bachelor’s degree in science or related field

Master’s degree preferred

Job description

Johnson & Johnson’s Leiden site seeks a Senior Manager Operations Data Integrity Lead to drive the Data Integrity and Data Governance framework across Biotherapeutics Operations. You will translate global requirements into practical standards and measurable improvements, partnering with Quality, Site Compliance, and Operations leaders to embed DI in shopfloor routines.

You will lead matrix teams, own the DI program, and ensure robust governance, audits, and CAPA outcomes while guiding risk-based