Technology Manager, Quality Systems, BA

Johnson & Johnson Innovative Medicine•Raynham, MA

13d•$102,000 - $177,100•Hybrid

About The Position

DePuy Synthes is recruiting a Technology Manager, Quality Systems, located in Raynham, Massachusetts; West Chester, Pennsylvania; New Brunswick, New Jersey; Palm Beach Gardens, Florida; or Warsaw, Indiana. The role leads the business analysis capability supporting enterprise quality systems within the Supply Chain Technology function and Quality sub-function. It manages individual contributors and/or supervisors and is accountable for performance management, capability building, and career development. The manager develops tactical and operational plans for quality systems requirements delivery and serves 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. The position requires up to 20% domestic travel across DePuy Synthes manufacturing and office sites. English proficiency is required. The anticipated base pay range is $102,000 to $177,100. The position is eligible for the company's long-term incentive program and, subject to applicable plans and policies, retirement and savings plans and various leave benefits. Following the planned separation of the Orthopaedics business, the role is anticipated to become employment with DePuy Synthes, subject to completion of the transaction and applicable conditions.

Requirements

Bachelor's degree in Information Systems, Computer Science, Industrial Engineering, Life Sciences, Quality, Business, or a related discipline.
At least 8 years of progressive experience in business analysis, systems analysis, or solution delivery for regulated business applications in a manufacturing or MedTech environment.
At least 2 years of experience leading teams, including managing performance, developing talent, and delivering results through others.
Hands-on experience gathering and documenting requirements for enterprise quality management systems such as Veeva Vault QMS, TrackWise, ETQ, Sparta, or equivalent.
Strong working knowledge of GxP, 21 CFR Part 11, computer system validation, and ALCOA+ data integrity requirements as they apply to requirements and design documentation.
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-state and future-state mapping and gap identification across regulated workflows.
Experience defining integration requirements between quality systems and ERP, PLM, or manufacturing platforms.
English proficiency.
Ability to travel domestically up to 20% across DePuy Synthes manufacturing and office sites.

Nice To Haves

Master's degree in Information Systems, Engineering, or Business Administration.
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 or LLM-enabled tooling to accelerate requirements drafting, test script generation, and documentation.
Proficiency with SQL and reporting tools such as Power BI or Tableau sufficient to validate data and define reporting requirements.
Exposure to intelligent automation, including RPA and 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.
CBAP, PMI-PBA, ASQ CQA, ITIL v4 Foundation, or relevant quality systems platform certification.

Responsibilities

Develop tactical and operational plans to achieve quality systems business analysis goals and communicate them to managers, supervisors, and individual contributors.
Direct requirements elicitation, analysis, and documentation across quality processes, including complaint handling, CAPA, nonconformance, deviations, change control, document management, training, and audit management.
Lead product functional design based on knowledge of quality system users, regulated processes, and platform capabilities.
Prioritize and maintain the backlog for assigned quality platforms, balancing requirements from Quality process owners, Regulatory, Manufacturing, and Technology stakeholders.
Oversee translation of business requirements into user stories, functional specifications, acceptance criteria, and traceability matrices suitable for a validated environment.
Direct current-state and future-state process analysis, identifying gaps, inefficiencies, and automation opportunities across quality workflows.
Govern solution design reviews to ensure configurations meet business needs, regulatory requirements, and platform architectural standards.
Lead user acceptance testing strategy and execution, including test script authorship, defect triage, and go/no-go recommendations.
Ensure requirements and design artifacts meet computer system validation, change control, and documentation obligations under GxP, 21 CFR Part 11, and ALCOA+ data integrity requirements.
Direct impact assessment and requirements definition for integrations between quality systems and ERP (SAP), PLM, manufacturing execution, and post-market surveillance platforms.
Partner with Quality leadership to define process and system KPIs and translate reporting needs into platform requirements.
Assess quality systems implications of technology changes, including platform migrations, ERP implementations, and separation or carve-out activity, and define requirements ahead of cutover.
Anticipate bottlenecks, manage escalations, and build consensus by understanding stakeholder requirements and constraints.
Lead business readiness, training material development, and change management to support adoption of new and enhanced quality system capabilities.
Manage team performance, capability building, and career development.

Benefits

Company consolidated retirement plan (pension), subject to the terms of the plan.
Savings plan (401(k)), subject to the terms of the plan.
Eligibility for the company's long-term incentive program.
Vacation: 120 hours per calendar year, subject to applicable policies and date of hire.
Sick time: 40 hours per calendar year, with different stated amounts for residents of Colorado and Washington.
Holiday pay, including floating holidays: 13 days per calendar year.
Work, Personal and Family Time: up to 40 hours per calendar year.
Parental Leave: 480 hours within one year of the birth, adoption, or foster care of a child.
Bereavement Leave: 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
Caregiver Leave: 80 hours in a 52-week rolling period.
Volunteer Leave: 32 hours per calendar year.
Military Spouse Time-Off: 80 hours per calendar year.