Technology Manager, Quality Systems, BA
Johnson & Johnson Innovative Medicine
Summary
DePuy Synthes is recruiting for a Technology Manager, Quality Systems, BA, located in Raynham, MA or West Chester, PA or New Brunswick, NJ or Palm Beach Gardens, FL or Warsaw, IN.
Job description
The Technology Manager, Quality Systems, BA leads the business analysis capability supporting DePuy Synthes enterprise quality systems within the Supply Chain Technology function, Quality sub-function. This role manages a team of individual contributors and/or supervisors and is accountable for effective performance management, capability building, and career development. The Manager develops tactical and operational plans for quality systems requirements delivery, serving as the primary bridge between Quality, Regulatory, and Manufacturing process owners and the technology teams that build and support validated quality platforms. The role leads requirements elicitation, process and system analysis, functional design, and user acceptance across complaint handling, CAPA, nonconformance, document management, training, and audit systems.
Key Responsibilities
- Develops tactical and operational plans to achieve quality systems business analysis goals, and communicates plans to managers, supervisors, and individual contributors.
- Directs requirements elicitation, analysis, and documentation across quality processes including complaint handling, CAPA, nonconformance, deviations, change control, document management, training, and audit management.
- Leads the product functional design process based on an intimate knowledge of quality system users, regulated processes, and platform capability.
- Prioritizes and maintains the backlog for assigned quality platforms, balancing the requirements of Quality process owners, Regulatory, Manufacturing, and Technology stakeholders.
- Oversees translation of business requirements into user stories, functional specifications, acceptance criteria, and traceability matrices suitable for a validated environment.
- Directs current-state and future-state process analysis, identifying gaps, inefficiencies, and automation opportunities across quality workflows.
- Governs solution design reviews to ensure proposed configurations meet business need, regulatory requirements, and platform architectural standards.
- Leads user acceptance testing strategy and execution, including test script authorship, defect triage, and go/no-go recommendation.
- Ensures requirements and design artifacts satisfy computer system validation, change control, and documentation obligations under GxP, 21 CFR Part 11, and data integrity (ALCOA+).
- Directs impact assessment and requirements definition for integrations between quality systems and ERP (SAP), PLM, manufacturing execution, and post-market surveillance platforms.
- Partners with Quality leadership to define process and system KPIs, and translates reporting needs into platform requirements.
- Assesses the quality systems implications of technology change — including platform migrations, ERP implementations, and separation/carve-out activity — and defines requirements ahead of cutover.
- Anticipates bottlenecks, provides escalation management, and builds consensus by understanding stakeholder requirements and constraints.
- Leads business readiness, training material development, and change management to support adoption of new and enhanced quality system capabilities.
Requirements
- Bachelor's degree in Information Systems, Computer Science, Industrial Engineering, Life Sciences, Quality, Business, or a related discipline
- 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
- English proficiency required
Benefits
- Pension
- 401(k)
- Long-term incentive program
- Vacation
- Sick time
- Holiday pay
- Floating holidays
- Parental leave
- Bereavement leave
- Caregiver leave
- Volunteer leave
- Military spouse time-off
- Medical benefits
Company overview
Johnson & Johnson Innovative Medicine is the pharmaceutical division of Johnson & Johnson, leading the way in medical innovation with a relentless focus on bringing transformational treatments to patients worldwide. The company applies rigorous science and compassion to address the most complex diseases of our time, developing groundbreaking medicines across key therapeutic areas including oncology, immunology, neuroscience, and cardiopulmonary medicine. With deep expertise and global reach, Johnson & Johnson Innovative Medicine reimagines how devastating diseases are treated and cured, delivering hope and better care for millions of patients and their families. The organization pioneers the path from laboratory research to clinical application, championing patients every step of the way while maintaining an unwavering commitment to scientific excellence and patient-centered innovation.