Lead, cGMP Compliance & Investigations

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

Job summary

Johnson & Johnson Innovative Medicine in Spring House, PA seeks a cGMP Compliance and Investigations Lead to drive deviation investigations and CAPA programs supporting cell therapy development and manufacturing. You will work across Manufacturing, QA, QC, and technical teams to ensure risk assessments and CAPAs are robust and inspection-ready.

The role requires leading complex investigations, regulatory awareness (FDA/EMA), and strong documentation practices, with a focus on continuous

Qualifications

• Bachelor’s degree in a scientific, engineering, quality, or related discipline.
• Progressive experience in pharma/biotech with cGMP investigations, deviations, CAPAs, or quality-system compliance.
• Ability to lead complex investigations and translate findings into CAPAs.
• Working knowledge of cGMP, FDA/EMA expectations, data integrity, and QMS.
• Experience authoring and reviewing controlled documents, investigation reports, CAPAs, change controls, and QA/IP responses.

Responsibilities

• Lead investigations of deviations, non-conformances, and atypical events with root-cause analysis.
• Develop, coordinate, verify effective CAPAs and preventative actions.
• Maintain compliant investigation and CAPA records; author SOPs and risk assessments.
• Track performance, provide trend reports and leadership updates.
• Assess regulatory gaps and translate into remediation plans.
• Support change-control activities and training needs.
• Collaborate with Manufacturing, QA, QC, and SMEs on issues.
• Serve as SME during audits and inspections; ensure inspection readiness.
• Facilitate cross-functional reviews and drive actions to closure.
• Coach colleagues on investigation practices and cGMP expectations.
• Identify continuous-improvement opportunities within the quality system.

Skills

Analytical Reasoning

Biochemistry

Chemistry

Collaboration

Data Quality

Problem Solving

Written Expression

Troubleshooting

Execution Focus

Pharmacogenetics

Molecular Diagnostics

Drug Discovery

Clinical Trial Protocols

Education

Bachelor’s degree in a scientific, engineering, quality, or related discipline

Advanced degree preferred

Tools

LIMS

SAP

MS Office

Job description

Johnson & Johnson Innovative Medicine in Spring House, PA seeks a cGMP Compliance and Investigations Lead to drive deviation investigations and CAPA programs supporting cell therapy development and manufacturing. You will work across Manufacturing, QA, QC, and technical teams to ensure risk assessments and CAPAs are robust and inspection-ready.

The role requires leading complex investigations, regulatory awareness (FDA/EMA), and strong documentation practices, with a focus on continuous