Senior Manager, Acquisitions, Divestitures and Remediation, Technology Quality

Job Function

Quality

Digital Quality

Professional

• Horsham, Pennsylvania, United States of America
• New Brunswick, New Jersey, United States of America
• Raritan, New Jersey, United States of America

We are searching for the best talent for a Senior Manager, Acquisitions, Divestitures and Remediation, Technology Quality to be based in Raritan, NJ;
New Brunswick, NJ; or Horsham, PA.

Purpose:

Technology Quality and Compliance (TQ&C) manages the Quality and Compliance strategy for IT systems including applications, infrastructure and digital health solutions for J&J. TQ&C is the Subject Matter Expert (SME) for validation/qualification of both applications and infrastructure in accordance with J&J’s Systems Development Life Cycle (SDLC) and Computer System Validation (CSV) Framework, assuring compliance across the enterprise with applicable global regulations, advising on quality matters, and assisting with closing compliance gaps related to audits and inspections.

A key function of this group is to utilize a data-driven approach to independent monitoring, to drive consistency of TQ&C processes, leading process improvements where gaps are noted.

The Senior Manager, Acquisitions, Divestitures and Remediation, Technology Quality is responsible for successful execution and implementation of acquisitions and divestitures in accordance with the defined business vision/strategy.

• Defining and Managing the Acquisitions, Divestitures and Remediation Operating Model
• Executing and implementing the strategy and framework for TQ assessments of IT systems, e.g. infrastructure, applications and healthcare technology systems conveyed from an acquisition
• Executing and implementing assessment tools reviewing the qualification and validation of conveyed IT GxP systems:
  Manufacturing, Lab, R&D, Infrastructure, IT Tools, Websites, Mobile Applications, Software as a Medical Device (SAMD), Supply Chain
• Executing and implementing the strategy for divesting IT Systems as part of a brand or company separation project
• Providing strategic direction and operational support to the individual project teams
• Ensuring/promoting early involvement of TQ&C in the design and development of applications and infrastructure to ensure automated and preventive controls are built in
• Managing the end-to-end quality process and strategies for building and execution of applications and supporting infrastructure
• Implementing and maintaining TQ acquisitions and divestitures metrics and reporting for TQ infrastructure, application, healthcare A&D activities such as assessments, integration, separation, and remediation
• Translating the TQ Acquisition and Divestiture strategy into functional operational plans and ensuring consistency for the Global TQ organization
• Contributing to the creation of strategies for the qualification and validation of new and emerging technologies
• Providing compliance guidance and support to the project teams to ensure successful delivery of the project end-to-end
• Ensuring 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
• Participating in audits, approving audit non‑conformity action plans, and approving closure of internal audit findings
• Assisting with incident management/CAPA and NC for the systems supported
• Managing the execution of TQ tasks according to the project plan, goals and timelines
• Supporting the allocation of resources by accurately communicating availability
• Managing resources (both internal and external) and ensuring availability for ongoing and upcoming initiatives/projects
• Reviewing and approving validation deliverables, such as Compliance Plans, User Requirements/User Stories, System Tests, User Acceptance Tests, Traceability Matrices, and Compliance Reports including final release and approval for production use
• Proactively monitoring systems and processes to ensure compliance with standard operating procedures and industry best practices
• Tracking and documenting quantifiable business results achieved from project work and writing success stories for publication that demonstrate the business value created by TQ&C
• Identifying potential opportunities to automate SDLC tasks (e.g., AI, RPA, etc.)
• Stakeholder Management:
  Recognizing and responding to stakeholder needs and ensuring commitments are delivered upon
• Providing partnership, insight and direction to cross‑functional business leaders and stakeholders regarding TQ policies, solutions and initiatives
• Building and maintaining trusting, collaborative relationships and partnerships with internal and external stakeholders
• Managing relationships with the TQ&C leaders and their teams to ensure seamless delivery of compliant acquired systems to EQ Deployment offices, including complete validation package and ongoing support resources
• Managing relationships with…