Technology Manager, Quality Systems, BA

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

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Technology Product & Platform Management

Job Sub Function:

Technical Product Management

Job Category:

People Leader

All Job Posting Locations:

Raynham, Massachusetts, United States of America

Job Description:

DePuy Synthes is recruiting for a Technology Manager, Quality Systems, BA ,locatedin Raynham, MA or West Chester, PA or New Brunswick, NJ or Palm Beach Gardens, FL or Warsaw, IN

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.
• Directsrequirementselicitation, 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 andmaintainsthe 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,identifyinggaps, inefficiencies, and automation opportunities across quality workflows.
• Governs solution design reviews to ensure proposed configurations meet businessneed, 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 underGxP, 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 leadershipto defineprocess and systemKPIs, andtranslatesreporting 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.

Qualifications

Education

• Required:Bachelor's degree in Information Systems, Computer Science,IndustrialEngineering, Life Sciences, Quality, Business, ora relateddiscipline.
• Preferred:Master's degree in Information Systems, Engineering, or Business Administration.

Experience and Skills

Required:

• 5+ years of progressive experience in business analysis, systems analysis, or solution delivery for regulated business applications in a manufacturing or MedTech environment.
• Experience with ETQ is highly preferred.
• Experience leading a technical team (employee or contract) is required.
• Experience with various Quality Management System software applications is preferred.
• 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 ofGxP, 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, andrequirementstraceability 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:

• MedTech or medical device experience; familiarity with ISO 13485, EU MDR, and FDA QSR/QMSR requirements.
• The preferred candidate will have worked directly with business leads to identify and implement functionality into computerized systems that support the Quality Management System for a medical device, pharmaceutical, or biotechnology company.
• 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 acceleraterequirementsdrafting, test script generation, and documentation.
• Proficiencywith SQL and reporting tools (Power BI, Tableau)sufficienttovalidatedata and define reporting requirements.
• Exposure tointelligent 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.

Other:

• Travel: Up to 20% domestic travel expected across DePuy Synthes manufacturing and office sites.
• Language: Englishproficiencyrequired.
• Certifications: CBAP, PMI-PBA, ASQ CQA, ITIL v4 Foundation, or relevant quality systems platform certification preferred.

For more information on how we support the whole health of our employees throughout their wellness,careerand life journey, please visit www.careers.jnj.com .

Johnson & Johnson announced plans to separate ourOrthopaedicsbusiness toestablisha standaloneorthopaedicscompany, operating as DePuySynthes. The process of the planned separation isanticipatedto be completed within 18 to24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may berequired, regulatory approvals and other customary conditions and approvals. Should you accept this position, it isanticipatedthat, following conclusion of the transaction, you would be an employee of DePuySynthesand your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes atan appropriate timeand subject to any necessary consultation processes.

Johnson & Johnsonisan Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal,stateor local law. We actively seek qualified candidates who areprotectedveterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnsoniscommitted to providing an interview process that isinclusive ofour applicants’ needs. If you are an individual with a disability and would like to requestan accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contactAskGSto be directed to your accommodation resource.

#LI-Hybrid

#DePuySynthesCareers

Required Skills:

Preferred Skills:

• Analytical Reasoning, Consulting, Cost Management, Developing Others, Human-Computer Interaction (HCI), Inclusive Leadership, Leadership, People Performance Management, Performance Measurement, Product Development, Product Strategies, Project Management Methodology (PMM), Research and Development, Resource Management, Software Development Management, Strategic Supply Chain Management, Team Management

The anticipated base pay range for this position is :

$105,000.00 - $181,700.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company’s long-term incentive program.

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation –120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year

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/foster care of a child

Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave – 80 hours in a 52-week rolling period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year

Additional information can be found through the link below.

Co-Ops and Intern Positions: Please use the following language:

Co-Ops/Interns are eligible to participate in Company sponsored employee medical benefits in accordance with the terms of the plan.

Co-Ops and Interns are eligible for the following sick time benefits: up to 40 hours per calendar year; for employees who reside in the State of Washington, up to 56 hours per calendar year.

Co-Ops and Interns are eligible to participate in the Company’s consolidated retirement plan (pension).

Positions Represented by CBA: Please use the following language:

This position is eligible for benefits to include medical, dental, vision and time off, as well as any others as provided for in the applicable Collective Bargaining Agreement.

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits