Data Integrity and Risk Management, Quality Systems

6062-Janssen Pharmaceuticals, Inc. Legal Entity; Spring Valley Estates (GA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Vacation -120 hours per year

Sick time - 40 hours per year

Paid holidays and leave

Job summary

Johnson & Johnson is seeking a Senior Quality Systems Specialist – Data Integrity and Risk Management in Athens, GA. You will proactively identify, assess, mitigate, and govern quality risks across the product lifecycle to ensure patient safety and regulatory compliance.

Lead complex risk assessments, partner with analytics teams to deliver insightful dashboards, and drive data-driven decision making. Strong communication and cross-functional collaboration are essential in this role.

Qualifications

• Bachelor's degree required (prefer data integrity, risk management, computer science, engineering).
• Two+ years in data analysis or similar role.
• Experience with risk assessment methodologies and risk-based decision making.
• GxP quality knowledge including 21 CFR Part 11/Annex 11, ICH Q7 and Q9.
• 2+ years in Quality Assurance within pharma/medical device/life sciences or other GxP regulated industry.
• Experience with data analytics/visualization tools (e.g., Tableau, Power BI, Python).
• Strong data structures and transformations knowledge.
• Experience with electronic Quality Management Systems.
• Proficiency in Microsoft Excel or similar BI tools.

Responsibilities

• Identify, assess, control and mitigate risks to patient and product safety.
• Own local site risk register and escalate to global platform as needed.
• Classify site level risks appropriately.
• Support digitalization/automation of quality risk management data.
• Document business critical issues and risk-based decisions.
• Lead risk assessment sessions and change management events.
• Partner with data analytics teams to create dashboards and reports.
• Identify trends and opportunities for data quality improvements.
• Collaborate cross-functionally to address data/reporting needs.
• Perform other quality-related duties as required.

Skills

Data analytics

Risk assessment

Quality systems

Documentation

Cross-functional collaboration

Communication

Problem solving

Attention to detail

Education

Bachelor's degree in Data Integrity/Risk Management/Engineering/CS

Tools

Domo

Tableau

Looker

Qlik

Power BI

Python

Excel

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Details

Job Function: Quality Job Sub Function: Quality Systems Job Category: Professional All Job Posting Locations: Athens, Georgia, United States of America

Job Description: The Senior Quality Systems Specialist - Data Integrity and Risk Management proactively contributes to risk identification, assessment, mitigation, governance, and reporting. Ensures communication and reporting efforts follow global and local requirements to produce value-added, actionable risk analytics and governance information. Oversees the local risk assessment periodic review program and ensures site adherence to periodic review schedules. Manages the local risk register and maintains active involvement in reporting out and up to the platform and risk management Community of Practice forums. Assists in the es and implementation of Risk Management Systems designed to identify, eliminate or reduce, and insure against potential risks to the organization. Assesses and improves quality analysis review process to identify control deficiencies, and to ensure the risk management process is operating effectively and efficiently. Leads and conducts complex risk assessments under minimal supervision, leading and ensuring proper execution and utilization of appropriate risk models.

Essential Job Duties and Responsibilities

• Responsible for identifying, assessing, controlling and mitigating risks to ensure patient safety and product safety, quality, and regulatory compliance (e.g., ICH Q9) throughout the product lifecycle.
• Provides accountability and ownership of the local site risk register including escalating to the global platform based on risk level.
• Responsible for ensuring that site level risks are appropriately classified.
• Supports the digitalization and automation of quality risk management data to drive data insights, and process innovation.
• Documents business critical issues and risks following integrated risked-based decision-making.
• Leads risk assessment sessions where required and as part of change management.
• Partners with data analytics team(s) and leverages data analytics tools to create dashboards, reports, and any additional ad-hoc requests impacting data integrity and risk management.
• Identification of trends and opportunities for improvements through analysis of complex datasets including monitoring for Systemic Issues and Significant Quality Issues requiring escalation.
• Collaborate cross-functionally to determine and address data and reporting needs.
• Performs other Quality-related job duties as required.

Qualifications

• A minimum of a bachelor's degree required (preferred: Data Integrity, Risk Management, Computer Science, Engineering Science or equivalent)
• Two or more years of experience mining and assessing data as a data analyst or similar role
• Hands-on experience with executing various risk assessment methodologies, tools and application of risk-based decision-making.
• Quality experience & applied knowledge of cGMPs including 21 CFR part 11 / Annex 11, ICH Q7 and Q9.
• A minimum of (2) years of experience in Quality Assurance within the pharmaceutical / medical device / life sciences and / or other GxP regulated industry.
• Experience using data analytics / visualization tools (e.g., Domo, Tableau, Looker, Qlik, Microsoft Power BI, Python) in data analysis;
• Solid understanding of data structures and transformations.
• Experience working with electronic Quality Management Systems
• Expert with Microsoft Excel or other business intelligence / analytical tools
• Preferred: Skilled in analytical and critical thinking used in problem solving techniques.
• Strong ability to prioritize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with other team members that may impact timely completion.
• Works effectively with people that have diverse work styles, talents and ideas.
• Excellent communication skills.
• May perform other duties as assigned.

Preferred Skills

• Analytical Reasoning
• Business Alignment
• Business Behaviour
• Coaching
• Collaboration
• Communication
• Compliance Management
• Data Compilation
• Data Quality
• Data Savvy
• Document Management
• Problem Solving
• Quality Auditing
• Quality Control (QC)
• Quality Management Systems (QMS)
• Quality Services
• Quality Standards
• Systems Analysis
• Training People

Pay Transparency

Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program.

• Vacation -120 hours per calendar year
• Sick time - 40 hours per calendar year
• for employees who reside in the State of Colorado -48 hours per calendar year
• for employees who reside in the State of Washington -56 hours per calendar year
• Holiday pay, including Floating Holidays -13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave - 240 hours for an immediate family member
• 40 hours for an extended family member per calendar year
• Caregiver Leave - 80 hours in a 52-week rolling period
• 10 days
• Volunteer Leave - 32 hours per calendar year
• Military Spouse Time-Off - 80 hours per calendar year
• For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

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