Data and Risk Mgmt Sr QS Specialist

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.