Johnson & Johnson · 13 hours ago
Senior Manager, Technology Quality - Orthopedics Separation
Raritan, NJ
Full-time
Onsite
Senior Level, Lead/Staff
$122K/yr - $213K/yr
10+ years expJohnson & Johnson is a leader in healthcare innovation, seeking a Senior Manager, Technology Quality - Orthopedics Separation. This role is responsible for executing and implementing Quality and Compliance strategies for IT systems related to the separation of the Orthopedics business, ensuring adherence to global regulations and quality standards.
Hospital & Health Care
Responsibilities
Leading TQ&C strategies for Separation of Depuy-Synthes business and related GxP Computerized Systems
Execute the Technology Quality (TQ) strategy for the Separation
Provide day-to-day operational support to manage Separation across the TQ organization
Implementing and executing the overall TQ Separation strategy and framework to include an assessment of IT systems for acquired businesses and developing a streamlined approach for divesting IT systems within the defined Quality Management Framework
Provide appropriate measures and monitoring for management reporting
Promote an environment which encourages the company’s credo and the value of a diverse workforce
Lead globally diverse teams in an inclusive environment
Serve as a trusted partner across the Technology Quality & Compliance organization, requiring strong collaboration skills at various levels within and outside the organization, and includes making recommendations for improvements relevant to senior level stakeholders
Ensure that all J&J quality standards and global regulatory requirements are being met (e.g. 21 CFR Part 11, Annex 11)
Ensure that building and execution activities include early involvement of quality in the design and development activities, building quality into the work product, building controls within the application/solution, and use of automation whenever feasible
Own the quality approach for systems and ensure teams are accountable for delivering on an end-to-end support model for systems in scope
Provide technical and procedural expertise/guidance to the project teams as well as aligning with both internal and external stakeholders
Planning, task and resource allocations, executing, coordinating and maintaining the validation activities for GxP systems/applications
Approval of SDLC / Validation documentation deliverables including the approval to release system implementation and/or changes for production use, will attend project team meetings and provide TQ&C compliance guidance
Responsible for executing and implementing the strategy and framework for TQ assessments of IT systems, e.g. infrastructure, applications and healthcare technology systems separated from J&J
Responsible for executing separation activities of the GxP systems: Manufacturing, Lab, R&D, Infrastructure, IT Tools, Websites, Mobile Applications, Software as a Medical Device (SAMD), Supply Chain
Ensure/promote early involvement of TQ&C in the design and development of applications and infrastructure to ensure automated and preventive controls are built in
Manage the end-to-end quality process and strategies for building and execution of applications and supporting infrastructure
As a Power User, ensure that all Technology Quality related projects go through the Intake process & manage budgets effectively to deliver values to business (Legal Entities Separations for Day 1, TSA etc)
Provide strategic direction and operational support to the individual project teams
Responsible for implementing and maintaining TQ separation metrics and reporting for TQ infrastructure, application, healthcare related activities
Provide compliance guidance and support to the project teams to ensure successful delivery of the project end-to-end
Ensure a high degree of inspection readiness in support of health authority inspections, audits (internal and external) and periodic reviews of applications and infrastructure in scope of the TQ&C portfolio
Participate in audits, approves audit non-conformity action plans, and approve closure of internal audit findings
Assist with incident management/CAPA and NC for the systems supported
Manage the execution of TQ tasks according to the project plan, goals and timelines
Support the allocation of resources by accurately communicating availability
Responsible for managing resources (both internal and external) and ensures availability for ongoing and upcoming initiatives/projects
Perform review and approval of validation deliverables, such as, but not limited to Compliance Plans, User Requirements/User Stories, System Tests, User Acceptance Tests, Traceability Matrices, and the Compliance Reports including final release and approval for production use
Lead/work with TQ&C Deployment Office representatives on the separation activities
Proactively monitor systems and processes to ensure compliance with standard operating procedures and industry best practices
Track and document quantifiable business results achieved from project work and write success stories for publication that demonstrate the business value created by TQ&C
Recognize and respond to stakeholder needs and ensure commitments are delivered upon
Provide partnership, insight and direction to cross-functional business leaders and stakeholders regarding TQ policies, solutions and initiatives
Build and maintain trusting, collaborative relationships and partnerships with internal and external stakeholders which help accomplish key business objectives, and help others to do the same
Manage relationships with the New Company TQ&C leaders and their teams to ensure seamless delivery of compliant separated systems to the new company. This includes but not limited to complete/accurate validation package, process/tools & resources for ongoing support (post integration)
Manage relationships with Regulatory Compliance, Business Quality Operations and Business Quality Assurance, J&J Technology, R&D Quality, Information Security Risk Management, Worldwide Records Information Management, Privacy, etc. for the separated business segment, globally
Apply comprehensive risk management approaches and Quality and Compliance Principles to address and propose mitigation for risks associated with Separation to new company, including Due Diligences
Utilize expert knowledge of quality risk management practices and lead and mentor the team with critical thinking and risk-based approaches to carry out validation of computerized systems and infrastructure, especially with reference to Separation/Divestiture and complexities (technology vs business processes). e.g. Defining overall validation and test strategies for acquiring systems, monitor risks throughout the execution, implement/test mitigations and/or workarounds
Proactively monitor/uncover any potential risks and partner with stakeholders on potential solutions; adopt quality processes (such as NC/CAPA) for deviations and defect management
Qualification
Required
A Bachelor's degree in Computer Science, Information Systems, Business Administration or other related field required; advanced degree preferred; solid, relevant experience may be substituted when appropriate; additional certifications a plus
A minimum of 10-12 years of progressive experience in the pharmaceutical/med device/biotech industry, with direct experience in Computerized System validation activities specifically in the areas of acquisitions and divestitures
3+ years of experience managing people
Strong problem-solving skills to assist in maintaining project progress and on design issues
Strong executive presence, communication and facilitation skills
Strong Decision-Making abilities, required to make decisions on quality and compliance issues as well as, management items
Excellent listening and analytical skills
Advanced Project and Portfolio Management Skills
Strong Customer Centric mindset, understands one's stakeholders and their needs and priorities and can drive service excellence by focusing on customer value particularly for new personnel joining J&J
Strong level of proactivity and resourcefulness to solve problems
Applies Design Thinking methodology, emphasizes the end user to ideate possible solutions
Strong ability to team with others and drive towards a common goal
Works effectively in a virtual team environment
Strong experience in computer systems validation in GxP environments in the pharmaceutical industry required
Strong understanding of data analytics
Working knowledge of cGMP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211 and Part 820, Annex 11 required
Working knowledge of PMO, SDLC, GAMP 5, and ITIL frameworks is highly desirable
Strong mastery of skills including, Quality Strategy, Applications and Infrastructure, Data Integrity, Quality Theory, Testing, Quality Management Systems
Advanced knowledge of Security Role Design and Segregation of Duties
Familiarity and awareness of cybersecurity and privacy principles and implications for quality and risk management
Understanding of Global and Regional GxP Regulations
Strong Experience of data analytics and Insights
Working Knowledge with Technology Risk Assessments
Preferred
Business Alignment
Collaborating
Compliance Management
Fact-Based Decision Making
Good Manufacturing Practices (GMP)
ISO 9001
Mentorship
Organizing
Quality Auditing
Quality Control (QC)
Quality Management Systems (QMS)
Quality Standards
Quality Validation
Regulatory Environment
Standard Operating Procedure (SOP)
Tactical Thinking
Technical Credibility
Benefits
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
Company
Johnson & Johnson
At Johnson & Johnson, we believe health is everything.
10001+ employees
H1B Sponsorship
Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not
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Funding
Current Stage
Late StageLeadership Team
Alex Gorsky
Former Chairman and CEO, Johnson & Johnson
Joaquin Duato
Chairman of the Board and Chief Executive Officer
Recent News
2025-10-07
2025-10-07
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