Quality Systems Tech Manager (Regulated MedTech)

Biopharma Asia; Raynham (MA); On-site; USD 105,000 - 182,000; Full time

Job summary

DePuy Synthes, part of Johnson & Johnson, seeks a Technology Manager, Quality Systems, BA to lead the business analysis function supporting enterprise quality platforms. You will bridge Quality, Regulatory, and Manufacturing with IT to deliver validated QA solutions.

Responsibilities include requirements elicitation, process design, and UAT across complaint handling, CAPA, document management, and audit systems while ensuring GLP/GxP compliance and data integrity.

Qualifications

• Requires 5+ years of business/solutions analysis for regulated manufacturing apps.
• Experience with quality management systems (QMS) such as ETQ, Veeva Vault QMS, TrackWise, or Sparta.
• Strong knowledge of GxP, 21 CFR Part 11, computer system validation, and ALCOA+ data integrity.

Responsibilities

• Develops tactical plans to achieve QA/quality systems BA goals.
• Directs requirements elicitation and documentation across QA processes.
• Leads product functional design with knowledge of QA users and platforms.
• Prioritizes and maintains backlogs for quality platforms and integrations.
• Oversees translation of requirements into user stories and specs.
• Guides current/future state process analysis and gap identification.
• Ensures designs meet regulatory standards and validation needs.
• Leads UAT strategy, scripting, defect triage and go/no-go decisions.
• Partner with QA leadership on KPI definition and reporting requirements.
• Travels up to 20% domestically for site responsibilities.

Skills

Analytical reasoning

Regulated systems

Requirements gathering

User acceptance testing

ERP integrations

Education

Bachelor's degree in Information Systems/CS/Engineering/Life Sciences

Master's degree preferred

Tools

ETQ

Veeva Vault QMS

TrackWise

ETQ/Spar ta (or equivalent)

SAP ERP

PLM systems

Job description

DePuy Synthes, part of Johnson & Johnson, seeks a Technology Manager, Quality Systems, BA to lead the business analysis function supporting enterprise quality platforms. You will bridge Quality, Regulatory, and Manufacturing with IT to deliver validated QA solutions.

Responsibilities include requirements elicitation, process design, and UAT across complaint handling, CAPA, document management, and audit systems while ensuring GLP/GxP compliance and data integrity.