Senior cGMP Investigations & CAPA Lead

6084-Janssen Research & Development, LLC Legal Entity; Spring House (PA); On-site; USD 76,000 - 122,000; Full time

Job summary

Johnson & Johnson is seeking a cGMP Compliance and Investigations Lead in Spring House, PA to champion deviation investigations, CAPA development, and risk-based remediation across cell therapy development and manufacturing.

The role requires regulatory knowledge (FDA/EMA) and strong collaboration with Manufacturing, QA, QC, and technical teams to ensure inspection readiness and continuous improvement.

Qualifications

• Bachelor’s degree in a scientific, engineering, quality, or related discipline.
• Advanced degree preferred.
• Experience with cGMP investigations, deviations, CAPAs, or quality-system compliance.
• Knowledge of FDA/EMA expectations and data integrity.
• Experience authoring investigation reports and change controls.
• Strong cross-functional collaboration and communication skills.

Responsibilities

• Lead investigations of deviations, non-conformances, laboratory or assay failures, and atypical events.
• Apply root cause analysis and risk assessments to determine impact.
• Develop and verify CAPAs addressing root causes and ensuring audit-readiness.
• Maintain investigation, CAPA, and change-control records; draft SOPs, reports, and risk assessments.
• Provide trend reports with actionable recommendations to leadership.
• Support regulatory gap assessments and change-control activities.

Skills

cGMP investigations

Root cause analysis

CAPA development

Regulatory compliance

FDA/EMA knowledge

Quality systems

Education

Bachelor's degree in science/engineering/quality

Tools

LIMS

SAP

MS Office

Job description

Johnson & Johnson is seeking a cGMP Compliance and Investigations Lead in Spring House, PA to champion deviation investigations, CAPA development, and risk-based remediation across cell therapy development and manufacturing.

The role requires regulatory knowledge (FDA/EMA) and strong collaboration with Manufacturing, QA, QC, and technical teams to ensure inspection readiness and continuous improvement.