Data and Risk Mgmt Sr QS 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

Role

Senior Quality Systems Specialist focusing on Data Integrity and Risk Management within Johnson & Johnson's pharmaceutical quality framework.

Objectives

proactively identify, assess, mitigate, and report risks to ensure patient safety, product quality, and regulatory compliance throughout the product lifecycle.

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

Qualifications

• bachelor’s degree (preferably in Data Integrity, Risk Management, or Engineering)
• at least two 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 (e.g., Tableau, Power BI, Python), and knowledge of cGMPs including 21 CFR Part 11, ICH Q7/Q9

Preferred

• strong analytical and critical thinking skills, effective communication, and ability to prioritize in high‑paced settings

High‑Value

• expertise in data‑driven risk management within regulated pharma, with a focus on patient and product safety, and experience supporting digital transformation initiatives

Location

Athens, Georgia, with a focus on compliance and risk governance in a GxP environment.