Quality Systems Tech Manager – GxP/QMS Leader

Johnson & Johnson Co.; Raynham (MA); On-site; USD 102,000 - 177,000; Full time

Job summary

Johnson & Johnson’s DePuy Synthes unit seeks a Technology Manager, Quality Systems, BA, to lead business analysis for enterprise quality platforms. You will collaborate with Quality, Regulatory, and Manufacturing to design, validate, and implement system capabilities across complaint handling, CAPA, document management, and audit systems.

You will guide requirements, write user stories, and manage test strategies, ensuring compliance with GxP, 21 CFR Part 11, and data integrity while driving

Qualifications

• Bachelor's degree in Information Systems, Computer Science, Industrial Engineering, Life Sciences, Quality, Business, or related field.
• Master's degree preferred in Information Systems, Engineering, or Business Administration.

Responsibilities

• Develops tactical and operational plans to achieve quality systems BA goals and communicates them to teams.
• Directs requirements elicitation, analysis, and documentation across quality processes.
• Leads product functional design with deep knowledge of quality system users and regulated processes.
• Prioritizes and maintains backlog for quality platforms with stakeholders.
• Translates business requirements into user stories and acceptance criteria for validated environments.
• Oversees current/future-state process analysis, identifies gaps and automation opportunities.
• Governs solution design reviews to meet regulatory and architectural standards.
• Leads UAT strategy and defect triage for validated releases.
• Ensures artifacts satisfy GxP, 21 CFR Part 11, and ALCOA+ data integrity.

Skills

Regulated systems

GxP compliance

Requirements elicitation

Team leadership

ERP integration

Validation

SQL reporting

Quality management systems

Education

Bachelor's degree

Master's degree (preferred)

Tools

Veeva Vault QMS

TrackWise

ETQ

Sparta

SAP

Power BI

Tableau

Job description

Johnson & Johnson’s DePuy Synthes unit seeks a Technology Manager, Quality Systems, BA, to lead business analysis for enterprise quality platforms. You will collaborate with Quality, Regulatory, and Manufacturing to design, validate, and implement system capabilities across complaint handling, CAPA, document management, and audit systems.

You will guide requirements, write user stories, and manage test strategies, ensuring compliance with GxP, 21 CFR Part 11, and data integrity while driving