Senior Manager, Acquisitions, Divestitures and Remediation, Technology Quality

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and 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.

Job Function:

Quality

Job Sub Function:

Digital Quality

Job Category:

Professional

All Job Posting Locations:

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

Job 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 sy