[Hiring] Senior Digital Quality Systems Business Analyst @Johnson & Johnson Innovative Medicine

Role Description

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) 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.

Requirements

• This position may require up to 5% domestic and international travel.

Benefits

• 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.