Sr Digital QS Business Analyst

Johnson and Johnson; Zug; Hybrid; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

Johnson & Johnson is seeking a Sr Digital QS Business Analyst in Zug, Switzerland. The role translates business needs into QS IT solutions across EtQ, PLM, and ComplianceWire ecosystems, supporting new deployments and system upgrades.

The position requires a Bachelor's degree and 4+ years in quality/manufacturing/R&D within regulated environments, with strong communication and project-management skills. Up to 5% travel may be required.

Qualifikationen

• Bachelor's degree or equivalent; field in Computer Science, Engineering, Life Sciences, or related is a plus.
• Minimum 4 years of quality, manufacturing, and/or R&D experience in a regulated industry.

Aufgaben

• Understand business partner needs and translate into IT solutions while balancing tradeoffs.
• Participate on MT-wide multi-functional teams to meet Quality Management System requirements.
• Lead deployments for new in-scope systems and platform upgrades.
• Improve and maintain in-scope systems, including access management, master data, interfaces, and validation.
• Coordinate surveillance of user accounts, data extraction, and analytics for compliance and projects.
• Develop and execute test scripts to ensure compliance of in-scope systems.
• Lead or support projects to support digital roadmap, acquisitions/divestitures, and organizational changes.
• Develop and maintain global procedures for PLM, Document Management, CAPA and NC for continuous improvement.
• Manage spending within approved budgets.
• Communicate issues or opportunities to management; supervise staff to follow Health, Safety and Environmental practices.
• Ensure compliance with all regulations and internal policies; perform additional duties as needed.

Kenntnisse

Quality

Problem Solving

Communication

Project Management

Teamwork

Regulatory Compliance

Ausbildung

Bachelor's degree

Tools

EtQ

LMS

PLM

ERP

Power Apps

Jobbeschreibung

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.

Job Function:

Quality

Job Sub Function:

Digital Quality

Job Category:

Professional

All Job Posting Locations:

Zug, Switzerland

Job Description:

About MedTech

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

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 countries that align with your preferred location:

US and Puerto Rico - Requisition Number: R-097444

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.

We are searching for the best talent for Sr Digital QS Business Analyst!

Purpose:

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.

You will be responsible for:

• 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.

Qualifications:

• 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.

Other:

• 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.

#LI-Remote

Required Skills:

Preferred Skills:

• 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