Responsibilities
* Defining and Managing the Acquisitions, Divestitures and Remediation Operating Model
o 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.
o 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.
o Responsible for executing and implementing the strategy for divesting IT Systems as part of a brand or company separation project.
o Provides strategic direction and operational support to the individual project teams.
o Ensures/promotes early involvement of TQ&C in the design and development of applications and infrastructure to ensure that automated and preventive controls are built in.
o Manages the end-to-end quality process and strategies for building and execution of applications and supporting infrastructure.
o 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.
o Translates the TQ Acquisition and Divestiture strategy into functional operational plans and ensures consistency for the Global TQ organization.
o Contributes to the creation of strategies for the qualification and validation of new and emerging technologies.
o Provides compliance guidance and support to the project teams to ensure successful delivery of the project end-to-end.
o 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.
o Participates in audits, approves audit non-conformity action plans, and approves closure of internal audit findings.
o Assists with incident management/CAPA and NC for the systems supported.
o Manages the execution of TQ tasks according to the project plan, goals and timelines.
o Supports the allocation of resources by accurately communicating availability.
o Responsible for managing resources (both internal and external) and ensures availability for ongoing and upcoming initiatives/projects.
o Performs review and approval of validation deliverables, such as 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.
o Proactively monitors systems and processes to ensure compliance with standard operating procedures and industry best practices.
o 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.
o Ability to identify potential opportunities to automate SDLC tasks (e.g. AI, RPA etc.).
* Stakeholder Management
o Recognizes and responds to stakeholder needs and ensures commitments are delivered upon.
o Provides partnership, insight and direction to cross-functional business leaders and stakeholders regarding TQ policies, solutions and initiatives.
o 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.
o Manages relationships with the TQ&C leaders and their teams to ensure seamless delivery of compliant acquired systems to EQ Deployment offices, including complete/accurate validation package, process/tools & resources for ongoing support (post integration).
o 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
o 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.
o 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).
o Defining overall validation and test strategies for acquiring systems, monitor risks throughout the execution, implement/test mitigations and/or workarounds.
o Proactively monitors/uncover any potential risks and partners with stakeholders on potential solutions; adopt quality processes (such as NC/CAPA) for deviations and defect management.
* Project Management
o Proactively partner with A&D office to understand & plan support for projects in the pipeline, clean sheet resources, engage with due diligence.
o Manage the initiative’s overall scope and schedule, while setting and aligning expectations.
o As a Power User, ensures that all Technology Quality related projects go through the Intake process & manage budgets/resources to effectively deliver value to business.
o Establish clear communication channel up/down within and outside of the organization, e.g. with TQ LT & Power User community.
o Develop/Leverage internal partnership for seamless transition of acquired/divested systems.
o Work with A&D Office in optimizing the Playbook.
Qualifications and 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 21CFRPart11, Part210, Part211, Part820, and Annex11.
* Working knowledge of PMO, SDLC, GAMP5, 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.
Salary
The anticipated base pay range for this position is: €96,000.00 – €165,025.00.
Benefits
* An annual bonus with set target (% of pay) depending on pay grade/location, based on the employee’s and company’s performance of the previous calendar year, or sales commissions.
* Vacation days.
* Parental leave for a minimum of 12 weeks.
* Bereavement leave.
* Caregiver leave.
* Volunteer leave.
* Well‑being reimbursement.
* Programs for financial, physical and mental health.
* Service anniversary and recognition awards.
* Eligibility for various insurance plans (employer and some location‑eligible dependents).
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