Senior Manager, Data Integrity & Operations Compliance

Johnson & Johnson Innovative Medicine; Titusville (NJ); On-site; USD 122,000 - 213,000; Full time

Job summary

Johnson & Johnson Innovative Medicine in Titusville, NJ seeks a Senior Manager Operations Data Integrity Lead to drive the Data Integrity framework across Biotherapeutics Operations, translating global regulatory requirements into practical standards, risk-based controls, governance routines, and measurable improvements. The role reports to the Sr.

Director Biotherapeutics Operations and partners with Quality, Site Compliance, MSAT, QC and Operations leaders to embed DI expectations into

Qualifications

• Bachelor’s degree in science or engineering or related discipline required; Master’s degree preferred.
• 8+ years in GMP-regulated manufacturing, operations, quality, or data integrity in biopharmaceuticals/pharma.
• Strong knowledge of EU GMP/EudraLex, FDA expectations, 21 CFR Part 11, ALCOA+ and data lifecycle management.
• Experience translating regulatory requirements into operational actions and governance routines.

Responsibilities

• Own and drive the Operations Compliance Programme across Biotherapeutics Operations.
• Serve as SPOC for Operations Compliance with Quality, IMRC and Operations leadership.
• Lead documentation discipline, escalation practices, and a strong compliance culture.
• Execute Site Quality Plan and ensure actions are prioritized, resourced and delivered.
• Provide clear compliance narratives to Leadership on status, risks and decisions.
• Lead inspection readiness and regulatory response, coordinating internal and external inspections.
• Own inspection responses from observation to closure with robust root cause analysis and CAPAs.
• Translate regulatory expectations into operational priorities and multi-year roadmaps.
• Sponsor strategic compliance initiatives to strengthen systems, processes, facilities and quality.
• Drive governance, KPIs, dashboards and maturity metrics for accountability.

Skills

Data governance

Regulatory compliance

GMP knowledge

Leadership without authority

Communication skills

Project management

Risk management

Education

Bachelor’s degree in science/engineering/related

Master’s degree preferred

Job description

Johnson & Johnson Innovative Medicine in Titusville, NJ seeks a Senior Manager Operations Data Integrity Lead to drive the Data Integrity framework across Biotherapeutics Operations, translating global regulatory requirements into practical standards, risk-based controls, governance routines, and measurable improvements. The role reports to the Sr.

Director Biotherapeutics Operations and partners with Quality, Site Compliance, MSAT, QC and Operations leaders to embed DI expectations into