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Salary: USD 102,000 - 204,000 / annual
Johnson & Johnson's DePuy Synthes (MedTech division) is recruiting a Technology Manager, Quality Systems, Business Analysis for their Raynham, MA location (with alternative sites in West Chester PA, New Brunswick NJ, Palm Beach Gardens FL, or Warsaw IN).
This is a people-management role leading a team of business analysts and/or supervisors within the Supply Chain Technology function, Quality sub-function. You will serve as the primary bridge between Quality, Regulatory, and Manufacturing process owners and the technology teams building and supporting validated quality platforms.
Key responsibilities include:
- Developing tactical and operational plans for quality systems business analysis, with accountability for team performance management, capability building, and career development
- Directing requirements elicitation, analysis, and documentation across quality processes (complaint handling, CAPA, nonconformance, deviations, change control, document management, training, audit management)
- Leading product functional design based on deep knowledge of quality system users, regulated processes, and platform capabilities
- Prioritizing and maintaining backlogs for assigned quality platforms, balancing stakeholder needs across Quality, Regulatory, Manufacturing, and Technology
- Overseeing translation of business requirements into user stories, functional specifications, acceptance criteria, and traceability matrices for validated environments
- Directing current-state and future-state process analysis to identify gaps, inefficiencies, and automation opportunities
- Governing solution design reviews to ensure compliance with business needs, regulatory requirements, and platform standards
- Leading user acceptance testing strategy and execution, including test script authorship, defect triage, and go/no-go recommendations
- Ensuring requirements and design artifacts satisfy GxP, 21 CFR Part 11, and ALCOA+ data integrity obligations
- Directing impact assessment and requirements definition for integrations between quality systems and ERP (SAP), PLM, manufacturing execution, and post-market surveillance platforms
- Partnering with Quality leadership to define process and system KPIs and translate reporting needs into platform requirements
- Assessing quality systems implications of technology change (platform migrations, ERP implementations, separations/carve-outs)
- Leading business readiness, training material development, and change management for new and enhanced quality system capabilities
This role is particularly relevant given DePuy Synthes' planned separation from Johnson & Johnson to become a standalone orthopaedics company (anticipated within 18-24 months). You would support the systems and processes required for this transition.
QUALIFICATIONS:
Required Education:
- Bachelor's degree in Information Systems, Computer Science, Industrial Engineering, Life Sciences, Quality, Business, or related discipline
Preferred Education:
- Master's degree in Information Systems, Engineering, or Business Administration
Required Experience and Skills:
- Minimum 8 years of progressive experience in business analysis, systems analysis, or solution delivery for regulated business applications in a manufacturing or MedTech environment
- Minimum 2 years of experience leading teams, with demonstrated ability to manage performance, develop talent, and deliver results through others
- Deep hands-on experience gathering and documenting requirements for enterprise quality management systems (e.g., Veeva Vault QMS, TrackWise, ETQ, Sparta, or equivalent)
- Strong working knowledge of GxP, 21 CFR Part 11, computer system validation, and data integrity (ALCOA+) requirements as they apply to requirements and design documentation
- Proven experience producing functional specifications, user stories, acceptance criteria, process flows, and requirements traceability matrices
- Experience leading user acceptance testing, defect management, and business readiness for validated system releases
- Strong process analysis skills, including current/future-state mapping and gap identification across regulated workflows
- Experience defining integration requirements between quality systems and ERP, PLM, or manufacturing platforms
Preferred Experience and Skills:
- MedTech or medical device experience; familiarity with ISO 13485, EU MDR, and FDA QSR/QMSR requirements
- Experience leading requirements and business readiness for quality systems migration or stand-up within a divestiture, carve-out, or standalone entity
- Familiarity with Agile/Scrum delivery and backlog-driven requirements management in a regulated context
- Experience applying Generative AI / LLM-enabled tooling to accelerate requirements drafting, test script generation, and documentation
- Proficiency with SQL and reporting tools (Power BI, Tableau) sufficient to validate data and define reporting requirements
- Exposure to intelligent automation (RPA, workflow automation) and its application to quality processes
- Experience supporting regulatory inspections and external audits from a systems requirements perspective
- Familiarity with cloud-based validated application delivery models
- Certifications: CBAP, PMI-PBA, ASQ CQA, ITIL v4 Foundation, or relevant quality systems platform certification
Other Requirements:
- Up to 20% domestic travel expected across DePuy Synthes manufacturing and office sites
- English proficiency required
