Senior Manager, Operations Data Integrity & Compliance
Johnson & Johnson
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Benefits offered by this job
Job summary
Johnson & Johnson in Leiden, Netherlands seeks a Senior Manager Operations Data Integrity Lead to drive the Data Integrity and Data Governance framework across Biotherapeutics Operations. You will translate regulatory expectations into practical standards, lead governance, and partner with Quality, Compliance, and Operations leaders to embed DI into shopfloor practices.
Reporting to the Senior Director Biotherapeutics Operations, you will own the compliance program, guide inspection readiness,
Qualifications
- Bachelor’s degree in science, engineering, biotechnology, pharmaceutical sciences, automation, quality, or a related discipline.
- 8+ years of 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, ALCOA+.
- Experience translating compliance gaps into operational actions, governance routines and remediation plans.
Responsibilities
- Own and drive the Operations Compliance Programme.
- Lead inspection readiness and regulatory response.
- Translate regulatory requirements into operational strategy and continuous improvement.
- Drive risk-based decision making and governance.
Skills
Education
Tools
Job description
Johnson & Johnson in Leiden, Netherlands seeks a Senior Manager Operations Data Integrity Lead to drive the Data Integrity and Data Governance framework across Biotherapeutics Operations. You will translate regulatory expectations into practical standards, lead governance, and partner with Quality, Compliance, and Operations leaders to embed DI into shopfloor practices.
Reporting to the Senior Director Biotherapeutics Operations, you will own the compliance program, guide inspection readiness,
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