Tech Manager, Quality Systems Leader
Biopharma Careers
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Benefits offered by this job
Job summary
Johnson & Johnson's DePuy Synthes unit seeks a Technology Mgr, Quality Systems, Analyst to lead enterprise quality platforms, manage a team, and drive the product roadmap across complaint handling, CAPA, nonconformance, document management, training, and audit platforms.
You will ensure GxP compliance, 21 CFR Part 11, and data integrity while advancing analytics, automation, and cross-functional collaboration.
Qualifications
- 8 years of progressive experience delivering and supporting enterprise quality systems or regulated business applications
- Experience leading teams and delivering results through others
- Experience owning product roadmaps and backlogs for regulated platforms
- Knowledge of GxP and 21 CFR Part 11 requirements
- Experience integrating quality systems with ERP/PLM/manufacturing systems
- Familiarity with AI-enabled tooling for quality processes
Responsibilities
- Develop tactical and operational plans to achieve quality systems goals and communicate plans to teams
- Own and execute the product roadmap for enterprise quality platforms
- Prioritize and maintain the backlog balancing needs of Quality, Regulatory, Manufacturing, and Technology
- Lead functional design for quality systems with user-centered insights
- Configure, enhance, and support validated quality platforms (complaint handling, CAPA, document control)
- Oversee analytics and reporting, defining metrics and dashboards for leadership visibility
- Ensure validation, change control, and data integrity compliance (ALCOA+, 21 CFR Part 11)
- Coordinate integration of quality systems with SAP, PLM, and manufacturing systems
- Identify automation opportunities and apply AI-enabled improvements with proper validation
- Manage vendor and MSP relationships with defined SLAs
- Serve as technology liaison for audits and inspections, providing evidence and documentation
- Assess impacts of technology changes on quality platforms and migrations
Skills
Education
Tools
Job description
Johnson & Johnson's DePuy Synthes unit seeks a Technology Mgr, Quality Systems, Analyst to lead enterprise quality platforms, manage a team, and drive the product roadmap across complaint handling, CAPA, nonconformance, document management, training, and audit platforms.
You will ensure GxP compliance, 21 CFR Part 11, and data integrity while advancing analytics, automation, and cross-functional collaboration.
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