Senior Quality Data Integrity & Risk Lead

6062-Janssen Pharmaceuticals, Inc. Legal Entity; Spring Valley Estates (GA); On-site; USD 79,000 - 128,000; Full time

Benefits offered by this job

Vacation –120 hours per year

Sick time –40 hours per year

Holiday pay –13 days per year

Parental Leave – 480 hours

Job summary

Johnson & Johnson in Georgia seeks a Senior Quality Systems Specialist – Data Integrity and Risk Management to drive risk governance and reporting. You will manage the local risk register, classify site risks, and work with analytics to deliver dashboards and insights for patient safety and regulatory compliance.

The role requires a BS in a related field, 2+ years in data analysis, and expertise in cGMPs. A fast-paced environment calls for strong collaboration and problem-solving skills.

Qualifications

• Bachelor’s degree required; data integrity or risk management preferred.
• 2+ years of data analysis experience in a data-driven role.
• Experience with risk assessment methodologies and cGMPs (21 CFR Part 11/Annex 11).
• Quality Assurance in pharmaceutical/medical device or GxP regulated industry.

Responsibilities

• Identify, assess, control and mitigate risks to patient and product safety and regulatory compliance.
• Own the local site risk register and escalate to the global platform as needed.
• Ensure site-level risks are properly classified and tracked.
• Support digitalization of quality risk data to drive insights and innovation.
• Lead risk assessment sessions and partner with analytics teams to create dashboards and reports.
• Analyze trends for systemic issues and communicate findings cross‑functionally.

Skills

Analytical Thinking

Data Analysis

Communication

Problem Solving

Quality Auditing

Education

Bachelor’s degree in Data Integrity, Risk Management, Computer Science, Engineering

Tools

Power BI

Tableau

Looker

Qlik

Python

Job description

Johnson & Johnson in Georgia seeks a Senior Quality Systems Specialist – Data Integrity and Risk Management to drive risk governance and reporting. You will manage the local risk register, classify site risks, and work with analytics to deliver dashboards and insights for patient safety and regulatory compliance.

The role requires a BS in a related field, 2+ years in data analysis, and expertise in cGMPs. A fast-paced environment calls for strong collaboration and problem-solving skills.