Sr Manager Operations DI Lead (Data Integrity)

Location: Titusville, New Jersey, United States of America; onsite

Salary: $122,000–$212,750 per year

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, documentation discipline, escalation practices, and compliance culture.
• Lead inspection readiness, inspection logistics, interview preparation, evidence management, responses, root cause analysis, and sustainable CAPAs.
• Translate regulatory expectations and compliance gaps into operational priorities, roadmaps, projects, and measurable outcomes.
• Establish risk-based governance, escalation pathways, KPIs, dashboards, maturity metrics, interim controls, and remediation plans.
• Influence Quality, Compliance, Automation, MSAT, QC, System Owners, SMEs, and Operations leaders through matrix leadership.

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, ALCOA+, data lifecycle management, and computerized system controls.
• Experience with deviations, non-conformance reporting, 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 a complex manufacturing environment.
• Strong written and verbal communication skills for leadership and inspection narratives.

Nice to have

• Coaching, collaboration, technical credibility, and fact-based decision making.
• ISO 9001, Lean Supply Chain Management, process improvement, quality control testing, and quality systems documentation.
• Quality validation, schematic design, tactical planning, and STEM application.

Culture & Benefits

• Inclusive work environment grounded in individual dignity, diversity, accountability, and continuous improvement.
• Additional employee benefits are available through the company benefits programme.