Data and Risk Mgmt Sr QS Specialist

Johnson & Johnson · Athens, GA

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QualityFull-time$79k–$128kCompany career page

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Role summary

Senior Quality Systems Specialist supporting risk identification, assessment, and mitigation across product lifecycles. Role oversees local risk registers, leads complex risk assessments, and partners with data analytics teams to drive quality and regulatory compliance in a pharmaceutical manufacturing environment.

What they're looking for

Bachelor's degree in Data Integrity, Risk Management, Computer Science, Engineering, or equivalent
Two or more years of data analysis or mining experience in a professional setting
Hands-on experience executing risk assessment methodologies and risk-based decision-making
Quality knowledge including cGMPs, 21 CFR Part 11, Annex 11, ICH Q7 and Q9
Minimum two years Quality Assurance experience in pharmaceutical, medical device, or GxP-regulated industry
Proficiency with data analytics and visualization tools such as Domo, Tableau, Power BI, or Python
Advanced proficiency with Microsoft Excel and business intelligence tools

What you'll be doing

Identify, assess, control, and mitigate risks to ensure patient safety, product quality, and regulatory compliance throughout product lifecycle
Manage local site risk register with accountability for escalation to global platform based on risk classification
Lead and conduct complex risk assessments and facilitate risk assessment sessions during change management
Partner with data analytics teams to create dashboards, reports, and analyze datasets for trends and systemic quality issues
Support digitalization and automation of quality risk management data to drive insights and process innovation

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