Sr Digital QS Business Analyst
Johnson & Johnson MedTech
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Benefits offered by this job
Job summary
Johnson & Johnson MedTech is seeking a Sr Digital QS Business Analyst to translate business needs into IT solutions for QS applications (EtQ, PLM, and ComplianceWire) within the Quality System program.
The role includes deployment leadership, validation, data governance, and collaboration with MT, Technology Quality and business units to ensure patient safety and adherence to quality and regulatory requirements. The position is hybrid and available across multiple US states and Puerto Rico.
Qualifications
- Bachelor’s degree or equivalent in a related field.
- 4+ years in quality, manufacturing, or R&D within a regulated environment.
- Strong communication, teamwork, and problem-solving skills.
- Knowledge of project management principles and SDLC/CSV familiarity.
Responsibilities
- Translate business needs into IT solutions for QS applications.
- Lead deployments and platform upgrades for in-scope systems.
- Maintain user access, master data, interfaces, and validation activities.
- Coordinate data extraction, analysis, and reporting for compliance.
- Develop and execute test scripts for regulatory compliance.
- Support projects related to acquisitions, divestitures, and network changes.
- Create and maintain global procedures for QS systems (PLM, DOC management, CAPA, NC).
- Monitor budgets and communicate issues to management.
- Ensure health, safety, and compliance with company guidelines.
Skills
Education
Tools
Job description
- Switzerland - Requisition Number: R- 100187
At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.
Quality
Digital Quality
Professional
Athens, Georgia, United States of America, Cincinnati, Ohio, United States of America, Cornelia, Georgia, United States of America, Danvers, Massachusetts, United States of America, Guaynabo, Puerto Rico, United States of America, Jacksonville, Florida, United States of America, Raritan, New Jersey, United States of America, Remote (US)
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
This is a hybrid role available in multiple states within the United States and Puerto Rico. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from various locations to apply and encourage you to review the following sites where this opportunity is available: Cincinnati, OH; Cornelia, GA; Athens, GA; Jacksonville, FL; Raritan, NJ; Danvers, MA; and Guaynabo, PR.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country that align with your preferred location:
- Switzerland - Requisition Number: R- 100187
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Remote work options may be considered on a case-by-case basis and if approved by the Company.
The Sr Digital QS Business Analyst is responsible for translating business requirements into system solutions for MedTech (MT) Quality System (QS) applications (including the EtQ, PLM, and ComplianceWire GxP ecosystems, hereafter referred to as in-scope systems) within the context of implementing new applications or technologies; upgrades and enhancements; acquisitions, divestitures, network changes, and organizational changes.
The Sr Digital QS Business Analyst will also be responsible for ongoing operational activities for these QS applications. Engages with teams across the MT businesses as well as Johnson & Johnson Technology and Technology Quality organizations to lead or support implementation of application solutions to drive execution simplification and value creation for the Business Units and to ensure patient safety, adherence to quality, compliance, and legal (as applicable) requirements. Supports computer system validation and business readiness activities intended to ensure effective quality system application implementations.
- Understand business partner needs and facilitate translation into IT solutions while balancing tradeoffs and business impact to resolve system issues.
- Participate on MT-wide multi-functional teams to integrate IT solutions to optimally meet the requirements of the Quality Management System and meet customer/patient needs.
- Lead deployments for new in-scope systems and capabilities as well as related platform implementations and upgrades.
- Lead improvements and maintenance of existing in-scope systems, including but not limited to user access management, master data management, configuration changes, interfaces, process changes, automation, remediation, and validation.
- Coordinate surveillance of user accounts and records, as well as data extraction, compilation, and analytics for compliance and sustainability or project support.
- Develop and execute test scripts to support compliance of in-scope systems
- Lead or support various projects as assigned by management and in support of our digital roadmap, including projects to support acquisitions & divestitures, network changes, and org changes (small enhancements to large program deployments).
- Develop and maintain global procedures and processes for in-scope systems associated with PLM, Document Management, CAPA and NC for continuous improvement.
- Manage spending within approved budgets.
- Responsible for communicating business-related issues or opportunities to next management level.
- For those who supervise or manage a staff (including contractors), responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Perform other duties assigned as needed.
- Minimum of a Bachelor’s degree or equivalent is required; a degree concentration in Computer Science, Engineering, Life Sciences, or related subject area is an asset.
- A minimum of 4 years of quality, manufacturing, and/or R&D experience within a regulated industry, is required.
- Strong communication, teamwork, and problem-solving skills are essential for success in this role.
- Proven understanding of project management principles.
- Ability to analyze, balance, and prioritize risk in a dynamic environment.
- Demonstrated commitment to prioritizing customer and patient needs.
- Proven track record implementing Quality System improvements to meet compliance and overall business goals.
- Experience with NC, CAPA, and change control.
- Demonstrated skill in effectively analyzing relevant information and reaching independent decisions in a timely manner.
- Above average digital literacy and command of commonly used business applications (i.e. Microsoft Office, Copilot AI).
- Additional experience with EtQ, Learning Management Systems (LMSs), Product Lifecycle Management (PLMs), ERP systems, and Power Apps is a plus.
- Knowledge of Software Development Lifecycle (SDLC) and Computer System Validation (CSV) processes is a plus.
- Position is ideally based on a hybrid work model, with 3 days onsite and 2 days remote.
- This position may require up to 5% domestic and international travel.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.
If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent’s consent for the background check
- Coaching
- Communication
- Compliance Management
- Continuous Improvement
- Controls Compliance
- Digital Assurance
- Econometric Models
- Issue Escalation
- Performance Measurement
- Problem Solving
- Process Optimization
- Quality Control (QC)
- Quality Management Systems (QMS)
- Quality Standards
- Regulatory Compliance
- Standard Operating Procedure (SOP)
- Technologically Savvy
$94,000.00 - $151,800.00
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)).
- 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
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