Senior Data Integrity & Risk Management Specialist

Scorpion Therapeutics; Athens (GA); On-site; USD 85,000 - 110,000; Full time

Job summary

Johnson & Johnson is seeking a Senior Quality Systems Specialist focusing on Data Integrity and Risk Management within its pharmaceutical quality framework in Athens, GA. You will proactively identify, assess, mitigate, and report risks to safeguard patient safety and product quality throughout the lifecycle.

Responsibilities include leading local risk assessments, guiding data-driven risk dashboards with Tableau/Power BI, and partnering with analytics teams to drive continuous improvement in

Qualifications

• Bachelor’s degree in Data Integrity, Risk Management, or Engineering.
• At least 2 years’ experience in data analysis, risk assessment methodologies, and quality assurance within GxP-regulated pharma or medtech environments.
• Hands-on experience with risk tools, data analytics platforms (Tableau, Power BI, Python), and knowledge of cGMPs including 21 CFR Part 11, ICH Q7/Q9.

Responsibilities

• Manage local risk assessment programs and risk register
• Lead complex risk assessments leveraging risk models
• Support digitalization and automation efforts for risk data
• Analyze datasets for trends, systemic issues, and quality improvements
• Collaborate cross-functionally with data analytics teams to develop dashboards and reports, applying data insights to risk management

Skills

Data analysis

Risk assessment methodologies

Quality assurance

cGMPs (21 CFR Part 11, ICH Q7/Q9)

Education

Bachelor’s degree in Data Integrity, Risk Management, or Engineering

Tools

Tableau

Power BI

Python

Job description

Johnson & Johnson is seeking a Senior Quality Systems Specialist focusing on Data Integrity and Risk Management within its pharmaceutical quality framework in Athens, GA. You will proactively identify, assess, mitigate, and report risks to safeguard patient safety and product quality throughout the lifecycle.

Responsibilities include leading local risk assessments, guiding data-driven risk dashboards with Tableau/Power BI, and partnering with analytics teams to drive continuous improvement in