Technology Mgr, Quality Systems, Analyst
Biopharma Careers
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Benefits offered by this job
Job summary
Johnson & Johnson's DePuy Synthes unit seeks a Technology Mgr, Quality Systems, Analyst to lead enterprise quality platforms, manage a team, and drive the product roadmap across complaint handling, CAPA, nonconformance, document management, training, and audit platforms.
You will ensure GxP compliance, 21 CFR Part 11, and data integrity while advancing analytics, automation, and cross-functional collaboration.
Qualifications
- 8 years of progressive experience delivering and supporting enterprise quality systems or regulated business applications
- Experience leading teams and delivering results through others
- Experience owning product roadmaps and backlogs for regulated platforms
- Knowledge of GxP and 21 CFR Part 11 requirements
- Experience integrating quality systems with ERP/PLM/manufacturing systems
- Familiarity with AI-enabled tooling for quality processes
Responsibilities
- Develop tactical and operational plans to achieve quality systems goals and communicate plans to teams
- Own and execute the product roadmap for enterprise quality platforms
- Prioritize and maintain the backlog balancing needs of Quality, Regulatory, Manufacturing, and Technology
- Lead functional design for quality systems with user-centered insights
- Configure, enhance, and support validated quality platforms (complaint handling, CAPA, document control)
- Oversee analytics and reporting, defining metrics and dashboards for leadership visibility
- Ensure validation, change control, and data integrity compliance (ALCOA+, 21 CFR Part 11)
- Coordinate integration of quality systems with SAP, PLM, and manufacturing systems
- Identify automation opportunities and apply AI-enabled improvements with proper validation
- Manage vendor and MSP relationships with defined SLAs
- Serve as technology liaison for audits and inspections, providing evidence and documentation
- Assess impacts of technology changes on quality platforms and migrations
Skills
Education
Tools
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,solutions 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.
Technology Product & Platform Management
Technical Product Management
People Leader
Raynham, Massachusetts, United States of America
DePuy Synthes is recruiting for a Technology Mgr, Quality Systems, Analyst , located in Raynham, MA or West Chester, PA or New Brunswick, NJ or Palm Beach Gardens, FL or Warsaw, IN.
The Technology Manager, Quality Systems, Analyst leads the technology 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 the quality systems portfolio, owns and executes the product roadmap across complaint handling, CAPA, nonconformance, document management, training, and audit platforms, and prioritizes and maintains the backlog balancing the requirements of Quality, Regulatory, Manufacturing, and Technology stakeholders. Operating in a regulated MedTech environment, the role ensures all platform changes meet GxP , 21 CFR Part 11, and data integrity requirements while driving analytics, automation, and continuous improvement across the quality technology landscape.
- Develops tactical and operational plans to achieve qualitysystemstechnology goals, and communicates plans to managers, supervisors, and individual contributors.
- Develops, owns, and executes the product roadmap for the enterprise quality systems portfolio, aligning platform capability to Quality and Regulatory strategy.
- Prioritizes andmaintainsthe backlog for assigned quality platforms, balancing the requirements of Quality process owners, Regulatory, Manufacturing, and Technology stakeholders.
- Leads the product functional design process based on an intimate knowledge of quality system users, regulated processes, and platform technology.
- Directsconfiguration, enhancement, and support of validated quality platforms covering complaint handling, CAPA, nonconformance, deviations, change control, document management, training records, and audit management.
- Oversees analytics and reporting capability across quality data, defining metrics, dashboards, and trend analysis that give Quality leadership visibility into record aging, cycle time, and compliance posture.
- Ensures all platform changes follow computer system validation, change control, and documentation requirements consistent with GxP , 21 CFR Part 11, and data integrity (ALCOA+) expectations.
- Directs integration of quality systems with ERP (SAP), PLM, manufacturing execution, and post-market surveillance systems.
- Identifiesand delivers automation and AI-enabled improvement opportunities across quality processes, ensuring appropriate validation and human-in-the-loop controls.
- Manages vendor and managed service partner relationships, including scope definition, quality of deliverables, and SLA performance.
- Serves as the technology point of contact for internal, external, and regulatory audits and inspections, coordinating evidence, validation documentation, and remediation.
- 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.
- Required: Bachelor's degree in Computer Science , Information Systems, Engineering, Life Sciences, Quality, Industrial Engineering or a related discipline.
- Preferred:Master's degree in Information Systems , Engineering, or Business Administration.
- 8 years of progressive experience delivering and supporting enterprise quality systems or 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 with enterprise quality management systems (e.g., Veeva Vault QMS, TrackWise , ETQ, Sparta, or equivalent) across complaint , CAPA, nonconformance, and document control processes.
- Strong working knowledge of GxP , 21 CFR Part 11, computer system validation, and data integrity (ALCOA+) requirements.
- Proven experience owning a product roadmap and backlog for a regulated platform portfolio.
- Experience defining quality metrics, analytics, and executive reporting from quality system data.
- Experience integrating quality systems with ERP (SAP), PLM, and manufacturing systems.
- Experience managing vendors, system integrators, or managed service partners against defined SLAs.
- Strong stakeholder management and communication skills, with proven ability to influence Quality and Regulatory leadership.
- MedTech or medical device experience; familiarity with ISO 13485, EU MDR, and FDA QSR/QMSR requirements.
- Experience leading qualitysystemsmigration, consolidation, or stand-up within a divestiture, carve-out, or standalone entity.
- Experience applying Generative AI / LLM-enabled tooling to complaint triage, document review, or quality record analysis, with appropriate validation controls.
- Familiarity with Agile/Scrum delivery and backlog-driven product management in a regulated context.
- Proficiency with reporting and visualization tools (Power BI, Tableau) and SQL for quality analytics.
- Exposure to intelligent automation platforms (RPA, workflow automation) applied to quality operations.
- Experience supporting regulatory inspections and external audits as a technology representative.
- Familiarity with cloud platforms (Azure, AWS) and validated cloud application management.
Travel: Up to 20% domestic travel expected across DePuy Synthes manufacturing and office sites.
Language: English proficiency required.
Certifications: Lean /Six Sigma, ASQ CQE/CQA, ITIL v4 Foundation, PMP, 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 ourOrthopaedicsbusiness toestablisha standalone ortopaedics 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,stateor local law. We actively seek qualified candidates who areprotected veterans 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.
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 : 102,000.00 - 204,000.00 USD
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)).
- 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
For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits
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