Senior Data Integrity & Compliance Lead, Operations

Biopharma Careers; Titusville (FL); On-site; USD 122,000 - 213,000; Full time

Job summary

Johnson & Johnson 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, regulatory expectations, and remediation priorities into practical standards, risk-based controls, governance routines, and measurable improvements.

The role reports to the Sr. Director Biotherapeutics Operations, partnering with Quality, Site Compliance, GET/JJT Automation, MSAT, QC, System

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 experience.
• Strong knowledge of EU GMP/EudraLex, Annex 11, FDA expectations, 21 CFR Part 11, ALCOA+, and related controls.
• Ability to translate compliance gaps into operational actions, governance routines, and remediation plans.

Responsibilities

• Own and drive the Operations Compliance Programme, partnering with Quality, IMRC and Operations leadership.
• Drive inspection readiness and manage regulatory responses with robust evidence and corrective actions.
• Translate regulatory requirements into operational strategy and multi-year compliance roadmaps.
• Drive risk-based decision making, governance, KPIs, dashboards, and accountability across teams.

Skills

Communication skills

Regulatory knowledge

Cross-functional leadership

CAPA & change control

Audit readiness

Data integrity

Education

Bachelor’s degree in science/engineering/... related discipline

Job description

Johnson & Johnson 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, regulatory expectations, and remediation priorities into practical standards, risk-based controls, governance routines, and measurable improvements.

The role reports to the Sr. Director Biotherapeutics Operations, partnering with Quality, Site Compliance, GET/JJT Automation, MSAT, QC, System