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 Function:
QualityJob Sub Function:
Quality SystemsJob Category:
ProfessionalAll Job Posting Locations:
Athens, Georgia, United States of AmericaJob 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.
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Alignment, Business Behavior, 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 PeopleThe anticipated base pay range for this position is :
$79,000.00 - $127,650.00Additional Description for 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.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
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 period10 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
Skills Required
- Bachelor's degree required, preferably in Data Integrity, Risk Management, Computer Science, Engineering Science, or an equivalent field
- Two or more years of experience mining and assessing data as a data analyst or in a similar role
- Hands-on experience executing risk assessment methodologies, tools, and risk-based decision-making
- Quality experience and applied knowledge of cGMP, 21 CFR Part 11, Annex 11, ICH Q7, and ICH Q9
- At least two years of Quality Assurance experience in pharmaceutical, medical device, life sciences, or another GxP-regulated industry
- Experience with data analytics and visualization tools such as Domo, Tableau, Looker, Qlik, Microsoft Power BI, or Python
- Understanding of data structures and transformations
- Experience working with electronic Quality Management Systems
- Expertise with Microsoft Excel or other business intelligence and analytical tools
- Analytical and critical-thinking skills for problem-solving techniques
- Ability to prioritize tasks and monitor assignments in a fast-paced environment
- Ability to work effectively with people with diverse work styles, talents, and ideas
- Excellent communication skills
Johnson & Johnson Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Johnson & Johnson and has not been reviewed or approved by Johnson & Johnson.
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Healthcare Strength — Healthcare coverage is characterized as comprehensive across medical, dental, and vision, with added supports like onsite clinics, fitness centers, and Employee Assistance resources. Mental-health services and wellbeing reimbursements are also described as meaningful components of the overall package.
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Retirement Support — Retirement offerings are portrayed as a major differentiator, combining a 401(k) with employer matching and an employer-funded pension plan. Stock options and other long-term financial supports are also positioned as part of the broader rewards mix.
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Parental & Family Support — Family-related benefits are presented as notably strong, including paid parental leave for all new parents and additional leave types for caregiving and bereavement. Financial assistance for adoption, fertility treatment, and surrogacy is highlighted as a significant support.
Johnson & Johnson Insights
What We Do
Profound Change Requires Boldness. Johnson & Johnson is the largest and most broadly based healthcare company in the world. We’re producing life-changing breakthroughs every day, and have been for the last 130 years. The combination of new technologies and your expertise enables amazing things to happen. Teams from J&J’s consumer business are creating digital tools to help people track the health of their skin. Those working in medical devices are 3-D printing artificial joints personalized for each patient, while researchers in pharmaceuticals use AI to discover lifesaving drugs. Imagine what the rest of our team of 134,000 people at 260 companies in more than 60 countries across the world is accomplishing. We redefine what it means to be a big company in today’s world. Social Media Community Guidelines: http://www.jnj.com/social-media-community-guidelines
