Data Integrity & Risk Management Lead (Quality Systems)

Biopharma Careers

Kentucky

On-site

USD 79,000 - 128,000

Full time

7 days ago
Be an early applicant
Application generator

An application made for this job — a tailored resume and cover letter that speak straight to the posting.

Get past ATS filters

Benefits offered by this job

Vacation 120 hours
Sick time
Holiday pay
Parental leave
Bereavement leave
Volunteer leave

Job summary

Johnson & Johnson is seeking a Senior Quality Systems Specialist – Data Integrity and Risk Management to proactively identify and mitigate risks across the product lifecycle. You’ll oversee the local risk register, drive governance reporting, and collaborate with analytics teams to deliver actionable insights.

The role requires a bachelor’s degree and 2+ years in data analysis, risk methods, and a strong grasp of quality systems and cGMP requirements.

Qualifications

  • Bachelor’s degree in a related field or equivalent.
  • Two+ years of data mining and data analysis experience.
  • Experience with risk assessment methodologies and decision-making.
  • Quality Assurance within pharma/medical device/life sciences environment.
  • Experience with data analytics tools and B.I. platforms.

Responsibilities

  • Identify, assess, control and mitigate risks to patient and product safety.
  • Own the local site risk register and escalate as needed.
  • Support digitalization of quality risk management data and dashboards.
  • Lead risk assessment sessions and drive change management.
  • Collaborate with data analytics teams to deliver insights.

Skills

Data analytics
Risk assessment
Quality systems
Communication skills
cGMP knowledge

Education

Bachelor's degree

Tools

Domo
Tableau
Looker
Qlik
Power BI
Python

Job description

Johnson & Johnson is seeking a Senior Quality Systems Specialist – Data Integrity and Risk Management to proactively identify and mitigate risks across the product lifecycle. You’ll oversee the local risk register, drive governance reporting, and collaborate with analytics teams to deliver actionable insights.

The role requires a bachelor’s degree and 2+ years in data analysis, risk methods, and a strong grasp of quality systems and cGMP requirements.

Get your free, confidential resume review.
or drag and drop your file here.
Similar jobs

Similar jobs worth comparing

Senior Data Integrity & Risk Management Specialist
Senior Data Integrity & Risk Management Specialist

Scorpion Therapeutics • Athens (GA)

On-site
USD 85,000 - 110,000
Data and Risk Mgmt Sr QS Specialist
Data and Risk Mgmt Sr QS Specialist

Scorpion Therapeutics • Athens (GA)

On-site
USD 85,000 - 110,000
Data Integrity and Risk Management, Quality Systems
Data Integrity and Risk Management, Quality Systems

Biopharma Careers • Kentucky

On-site
USD 79,000 - 128,000
Vacation 120 hours
Sick time
Holiday pay
+3
Tech Manager, Quality Systems Leader
Tech Manager, Quality Systems Leader

Biopharma Careers • Raynham (MA)

On-site
USD 102,000 - 204,000
Vacation –120 hours per year
Sick time –40 hours per year
Holiday pay
Data Quality Manager — AI-Ready Data Platform
Data Quality Manager — AI-Ready Data Platform

Biopharma Careers • Titusville (FL)

On-site
USD 117,000 - 201,000
Medical
Dental
Vision
+4
Data Quality Leader, Enterprise Data Platform
Data Quality Leader, Enterprise Data Platform

Johnson & Johnson • Titusville (NJ)

On-site
USD 117,000 - 201,000
Tech Manager, Quality Systems — MedTech Analytics Leader
Tech Manager, Quality Systems — MedTech Analytics Leader

Relha LLC • Raynham (MA)

Hybrid
USD 102,000 - 204,000
Travel up to 20% domestic travel
401(k) / Pension plans
Senior Quality Engineer - MedTech Lifecycle & Compliance
Senior Quality Engineer - MedTech Lifecycle & Compliance

Johnson & Johnson MedTech • Cincinnati (OH)

On-site
USD 92,000 - 148,000
Vacation 120 hours/year
Sick time 40 hours/year
Holiday pay
Senior Manager - Data-Driven Healthcare Compliance Monitoring
Senior Manager - Data-Driven Healthcare Compliance Monitoring

Scorpion Therapeutics • Horsham (PA)

On-site
USD 120,000 - 160,000
Pharmacovigilance QA Leader — Audits & Compliance
Pharmacovigilance QA Leader — Audits & Compliance

Biopharma Careers • Raritan (NJ)

On-site
USD 102,000 - 177,000