Raritan, New Jersey, United States of America, United States of America
Hybrid
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Job Function:
QualityJob Sub Function:
Digital QualityJob Category:
ProfessionalAll Job Posting Locations:
Horsham, Pennsylvania, United States of America, New Brunswick, New Jersey, United States of America, Raritan, New Jersey, United States of AmericaJob Description:
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.
You will be responsible for:
1. Defining and Managing the Acquisitions, Divestitures and Remediation Operating Model
Responsible for 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
Responsible for 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
Responsible for executing and implementing the strategy for divesting IT Systems as part of a brand or company separation project
Provides strategic direction and operational support to the individual project teams
Ensures/promotes early involvement of TQ&C in the design and development of applications and infrastructure to ensure automated and preventive controls are built in
Manages the end-to-end quality process and strategies for building and execution of applications and supporting infrastructure
Responsible for 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
Translates the TQ Acquisition and Divestiture strategy into functional operational plans and ensure consistency for the Global TQ organization
Contributes to the creation of strategies for the qualification and validation of new and emerging technologies
Provides compliance guidance and support to the project teams to ensure successful delivery of the project end-to-end
Ensures 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
Assists with incident management/CAPA and NC for the systems supported
Manages the execution of TQ tasks according to the project plan, goals and timelines
Supports 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
Performs 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
Proactively monitors systems and processes to ensure compliance with standard operating procedures and industry best practices
Tracks and documents quantifiable business results achieved from project work and writes success stories for publication that demonstrate the business value created by TQ&C.
Ability to identify potential opportunities to automate SDLC tasks (e.g. AI, RPA etc).
2. Stakeholder Management
Recognizes and responds to stakeholder needs and ensures commitments are delivered upon
Provides partnership, insight and direction to cross-functional business leaders and stakeholders regarding TQ policies, solutions and initiatives
Builds and maintains trusting, collaborative relationships and partnerships with internal and external stakeholders which help accomplish key business objectives, and helps others to do the same
Manages relationships with the TQ&C leaders and their teams to ensure seamless delivery of compliant acquired systems to EQ Deployment offices. This includes but not limited to complete/accurate validation package, process/tools & resources for ongoing support (post integration).
Manages 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 A&D business segment, globally
3. Risk Management
Applies comprehensive risk management approaches and Quality and Compliance Principles to address and propose mitigating for risks associated with acquisitions and divestitures, including Due Diligences.
Utilizes expert knowledge of quality risk management practices and leads and mentors the team with critical thinking and risk-based approaches to carry out validation of computerized systems and infrastructure, especially with reference to Acquisitions/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.
4. Project Management
Proactively partner with A&D office to understand & plan support for projects in the pipeline, clean sheet resources, engage with due diligence.
Manage the initiative’s overall scope and schedule, while setting and aligning expectations.
As a Power User, ensures that all Technology Quality related projects go through the Intake process & manage budgets/resources to effectively to deliver values to business.
Establish clear communication channel up/down within and outside of the organization. E.g. with TQ LT & Power User community.
Develop/Leverage internal partnership for seamless transition of acquired/divested systems.
Work with A&D Office in optimizing the Playbook.
Qualifications/Requirements:
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
Belgium - Requisition Number: R-079767
Brazil - Requisition Number: R-079763
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
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, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Compliance Management, Controls Compliance, Digital Assurance, Digital Governance, Fact-Based Decision Making, Human-Computer Relationships, Organizing, Performance Measurement, Process Optimization, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Quality Validation, Regulatory Compliance, Researching, Stakeholder Engagement, Standard Operating Procedure (SOP), Technical Credibility
The anticipated base pay range for this position is :
$122,000.00 - $212,750.00Additional 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)).Want to know if this job is worth applying to?