Senior Data Integrity & Risk Lead, Quality Systems

Johnson & Johnson Innovative Medicine; Athens (GA); On-site; USD 79,000 - 128,000; Full time

Benefits offered by this job

Retirement plan

Long-term incentive program

Paid time off

Job summary

Johnson & Johnson Innovative Medicine in the United States seeks a Senior Quality Systems Specialist focused on Data Integrity and Risk Management. You will identify, assess, and mitigate risks across the product lifecycle, drive governance, and deliver actionable risk analytics to stakeholders.

You’ll oversee local risk registers, contribute to risk models, and collaborate with analytics teams to build dashboards and reports supporting patient safety and compliance.

Qualifications

• Bachelor’s degree in a relevant field (Data Integrity, Risk Management, CS, or Engineering)
• At least 2 years of data mining/analysis experience in a data analyst role
• Experience with risk assessment methodologies and risk-based decision making
• Quality experience with cGMPs including 21 CFR Part 11/Annex 11, ICH Q7 and Q9
• 2+ years QA experience in pharma/medical device or GxP industries
• Experience with data analytics/visualization tools (Domo, Tableau, Looker, Qlik, Power BI, Python)
• Solid understanding of data structures and transformations
• Proficient with Excel or BI tools

Responsibilities

• Identify, assess, controlling and mitigating risks to ensure patient and product safety, and regulatory compliance (ICH Q9) across the lifecycle
• Own and escalate site local risk register and classify site risks
• Support digitalization and automation of quality risk data to drive insights
• Document business-critical issues and risks using risk-based decision making
• Lead risk assessment sessions during change management
• Collaborate with data analytics teams to create dashboards and reports for data integrity and risk management
• Identify trends and opportunities for improvements through complex data analysis
• Collaborate cross-functionally to address data and reporting needs

Skills

Data analysis

Risk assessment

Quality Assurance (GxP)

Data visualization tools

Excel / BI tools

Communication

Education

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

Tools

Domo

Tableau

Looker

Qlik

Power BI

Python

Job description

Johnson & Johnson Innovative Medicine in the United States seeks a Senior Quality Systems Specialist focused on Data Integrity and Risk Management. You will identify, assess, and mitigate risks across the product lifecycle, drive governance, and deliver actionable risk analytics to stakeholders.

You’ll oversee local risk registers, contribute to risk models, and collaborate with analytics teams to build dashboards and reports supporting patient safety and compliance.