Data and Risk Mgmt Sr QS Specialist

Location: Athens, Georgia, United States of America; onsite

Salary: $79,000–$127,650 per year

Company

Johnson & Johnson MedTech develops healthcare and medical technology solutions focused on preventing, treating, and curing complex diseases.

What you will do

• Identify, assess, classify, control, and mitigate risks affecting patient safety, product safety, quality, and regulatory compliance across the product lifecycle.
• Own the local site risk register, escalate risks to the global platform when appropriate, and support risk governance forums.
• Lead complex risk assessments and facilitate risk assessment sessions during change management activities.
• Support the digitalization and automation of quality risk management data.
• Partner with data analytics teams to create dashboards, reports, and ad hoc analyses using complex datasets.
• Identify trends, control deficiencies, systemic issues, and significant quality issues requiring escalation.

Requirements

• Bachelor’s degree in data integrity, risk management, computer science, engineering science, or an equivalent field.
• At least two years of experience mining and assessing data as a data analyst or in a similar role.
• At least two years of Quality Assurance experience in pharmaceutical, medical device, life sciences, or another GxP-regulated industry.
• Hands-on experience with risk assessment methodologies, tools, risk models, and risk-based decision-making.
• Applied knowledge of cGMPs, including 21 CFR Part 11, Annex 11, ICH Q7, and ICH Q9.
• Experience with data analytics and visualization tools such as Domo, Tableau, Looker, Qlik, Microsoft Power BI, or Python, plus advanced Microsoft Excel skills and knowledge of data structures and transformations.

Nice to have

• Strong analytical and critical-thinking skills for problem solving.
• Ability to prioritize multiple assignments in a fast-paced environment.
• Excellent communication and cross-functional collaboration skills.

Culture & Benefits

• Inclusive work environment grounded in the company’s Credo.
• Eligibility for pension and 401(k) savings plans.
• Participation in the long-term incentive program.
• Paid vacation, sick time, holidays, personal and family time, parental leave, bereavement leave, caregiver leave, volunteer leave, and military spouse time off.