Senior Manager, Acquisitions, Divestitures and Remediation, Technology Quality

Johnson & Johnson • New Brunswick, NJ

17d • Hybrid

About The Position

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.

Requirements

• 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 8–10 years of progressive experience in the pharmaceutical/med device/biotech industry, with direct experience in Computerized System Validation (CSV), particularly in acquisitions and divestitures
• Strong ability to work effectively in a highly matrixed, global team environment
• Strong ability to effectively and productively communicate with external and internal stakeholders
• Strong cross-boundary collaboration, interdependent partnering, and influencing skills
• Ability to make decisions by building and maintaining trusting, collaborative relationships to meet business needs
• Proven ability to lead people and guide them through change in a complex environment
• Ability to inspire trust and quickly build credibility
• Excellent listening skills with the ability to incorporate diverse perspectives
• Strong learning agility; demonstrates ability and willingness to continuously learn and remain current in the marketplace
• Strong problem-solving skills to maintain project progress and resolve design issues
• Strong executive presence, communication, and facilitation skills
• Strong decision-making abilities, including decisions on quality, compliance, and management matters
• Strong analytical skills
• Ability to quickly understand the business being integrated or separated and related processes
• Financial acumen with understanding of how services contribute to cost and/or revenue
• Advanced project and portfolio management skills
• Strong project management, planning, and organizational skills
• Strong customer-centric mindset, with a focus on stakeholder needs and delivering service excellence (especially for new personnel during acquisitions)
• High level of proactivity and resourcefulness in problem-solving
• Applies design thinking methodology with a focus on end-user solutions
• Strong teamwork and ability to drive toward common goals
• Ability to work effectively in a virtual team environment
• Strong experience in computerized system validation (CSV) in GxP environments within the pharmaceutical industry
• Strong understanding of data analytics and insights
• Working knowledge of cGMP regulations related to CSV, including 21 CFR Part 11, Part 210, Part 211, Part 820, and Annex 11
• Working knowledge of PMO, SDLC, GAMP 5, and ITIL frameworks
• Strong mastery of quality-related competencies, including Quality Strategy, Applications & Infrastructure, Data Integrity, Testing, and Quality Management Systems
• Advanced knowledge of security role design and segregation of duties
• Familiarity with cybersecurity and privacy principles as they relate to quality and risk management
• Understanding of global and regional GxP regulations
• Experience with technology risk assessments

Nice To Haves

• advanced degree preferred
• additional certifications a plus

Responsibilities

• 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).
• 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
• 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.
• 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.

Benefits

• 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 period
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior