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.
Qualifications
Education
Required: Bachelor's degree in Information Systems, Computer Science, Industrial Engineering, Life Sciences, Quality, Business, or a related discipline.
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 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
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 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.
Other
Travel: Up to 20% domestic travel expected across DePuy Synthes manufacturing and office sites.
Language: English proficiency required.
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, career and life journey, please visit www.careers.jnj.com.
Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and 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 at an appropriate time and subject to any necessary consultation processes.
Johnson & Johnson is an 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, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers, internal employees contact AskGS to be directed to your accommodation resource.
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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
