Senior Quality & Data Integrity Risk Specialist

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

Benefits offered by this job

Vacation hours

Sick time

Holiday pay

Parental leave

Bereavement leave

Volunteer leave

Military time-off

Job summary

Johnson & Johnson Innovative Medicine seeks a Senior Quality Systems Specialist to strengthen data integrity and risk governance at the Athens site. You will drive risk identification, assessment, and reporting in collaboration with global platforms, ensuring compliance with ICH Q9, 21 CFR Part 11, and Annex 11.

You will lead complex risk assessments, develop dashboards with Power BI and other tools, and partner with data analytics teams to turn insights into action, while supporting process

Qualifications

• Bachelor’s degree required; preferred in Data Integrity, Risk Management, CS or Engineering.
• Minimum 2+ years of data mining and analysis experience.
• Experience with risk assessment methodologies and risk-based decision making.
• Quality experience with cGMPs including 21 CFR 11/Annex 11, ICH Q7 and Q9.
• 2+ years in QA within pharma/medical device or life sciences and/or other GxP.
• Experience with data analytics/visualization tools (Domo, Tableau, Looker, Qlik, Power BI, Python).
• Experience with electronic Quality Management Systems.
• Advanced Excel or equivalent BI tools.

Responsibilities

• Identify, assess, control and mitigate risks to patient and product safety.
• Own local site risk register and escalation to global platform.
• Support digitalization of quality risk management data.
• Document business-critical issues and risk-based decisions.
• Lead risk assessment sessions as needed.
• Partner with data analytics teams to create dashboards and reports.
• Identify trends and opportunities from complex datasets.
• Collaborate cross-functionally to address data and reporting needs.
• Perform other quality duties as required.

Skills

Data analysis

Risk assessment

Quality systems

Excel

QMS tools

Python

Data visualization

Education

Bachelor's degree

Tools

Domo

Tableau

Looker

Qlik

Power BI

Python

Job description

Johnson & Johnson Innovative Medicine seeks a Senior Quality Systems Specialist to strengthen data integrity and risk governance at the Athens site. You will drive risk identification, assessment, and reporting in collaboration with global platforms, ensuring compliance with ICH Q9, 21 CFR Part 11, and Annex 11.

You will lead complex risk assessments, develop dashboards with Power BI and other tools, and partner with data analytics teams to turn insights into action, while supporting process