Senior Quality Risk & Data Integrity Specialist

6062-Janssen Pharmaceuticals, Inc. Legal Entity; Spring Valley Estates (GA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Vacation -120 hours per year

Sick time - 40 hours per year

Paid holidays and leave

Job summary

Johnson & Johnson is seeking a Senior Quality Systems Specialist – Data Integrity and Risk Management in Athens, GA. You will proactively identify, assess, mitigate, and govern quality risks across the product lifecycle to ensure patient safety and regulatory compliance.

Lead complex risk assessments, partner with analytics teams to deliver insightful dashboards, and drive data-driven decision making. Strong communication and cross-functional collaboration are essential in this role.

Qualifications

• Bachelor's degree required (prefer data integrity, risk management, computer science, engineering).
• Two+ years in data analysis or similar role.
• Experience with risk assessment methodologies and risk-based decision making.
• GxP quality knowledge including 21 CFR Part 11/Annex 11, ICH Q7 and Q9.
• 2+ years in Quality Assurance within pharma/medical device/life sciences or other GxP regulated industry.
• Experience with data analytics/visualization tools (e.g., Tableau, Power BI, Python).
• Strong data structures and transformations knowledge.
• Experience with electronic Quality Management Systems.
• Proficiency in Microsoft Excel or similar BI tools.

Responsibilities

• Identify, assess, control and mitigate risks to patient and product safety.
• Own local site risk register and escalate to global platform as needed.
• Classify site level risks appropriately.
• Support digitalization/automation of quality risk management data.
• Document business critical issues and risk-based decisions.
• Lead risk assessment sessions and change management events.
• Partner with data analytics teams to create dashboards and reports.
• Identify trends and opportunities for data quality improvements.
• Collaborate cross-functionally to address data/reporting needs.
• Perform other quality-related duties as required.

Skills

Data analytics

Risk assessment

Quality systems

Documentation

Cross-functional collaboration

Communication

Problem solving

Attention to detail

Education

Bachelor's degree in Data Integrity/Risk Management/Engineering/CS

Tools

Domo

Tableau

Looker

Qlik

Power BI

Python

Excel

Job description

Johnson & Johnson is seeking a Senior Quality Systems Specialist – Data Integrity and Risk Management in Athens, GA. You will proactively identify, assess, mitigate, and govern quality risks across the product lifecycle to ensure patient safety and regulatory compliance.

Lead complex risk assessments, partner with analytics teams to deliver insightful dashboards, and drive data-driven decision making. Strong communication and cross-functional collaboration are essential in this role.