cGMP Compliance & Investigations Lead – Cell Therapy

Johnson & Johnson Co.; Spring House (PA); On-site; USD 76,000 - 122,000; Full time

Job summary

Johnson & Johnson, a world leader in health care, seeks a cGMP Compliance and Investigations Lead for its Innovative Medicine team in Spring House, PA. You will guide investigations, CAPA development, and regulatory readiness across QA/QC and manufacturing functions.

The role requires in-depth knowledge of cGMP, FDA/EMA expectations, data integrity, and documented quality systems. You will drive risk assessments, change controls, and continuous improvement initiatives in a collaborative

Qualifications

• Bachelor's degree in a scientific, engineering, quality, or related discipline is required.
• Advanced degree is preferred.
• Experience leading cGMP investigations, deviations, CAPAs, or quality-system compliance.

Responsibilities

• Lead complex investigations of deviations, non-conformances, and assay problems with root cause analysis.
• Develop, coordinate, verify CAPAs addressing root causes and compliance needs.
• Maintain investigation and change-control records with supporting documentation.
• Draft and revise SOPs, risk assessments, and technical reports.
• Provide risk-based remediation plans and trend reports to leadership.

Skills

Analytical thinking

Facilitation

Project management

Problem solving

Education

Bachelor's degree in science/engineering/quality

Advanced degree preferred

Tools

SAP

LIMS

MES/PAS-X

Job description

Johnson & Johnson, a world leader in health care, seeks a cGMP Compliance and Investigations Lead for its Innovative Medicine team in Spring House, PA. You will guide investigations, CAPA development, and regulatory readiness across QA/QC and manufacturing functions.

The role requires in-depth knowledge of cGMP, FDA/EMA expectations, data integrity, and documented quality systems. You will drive risk assessments, change controls, and continuous improvement initiatives in a collaborative