Ph3Responsibilities /h3ullibDefining and Managing the Acquisitions, Divestitures and Remediation Operating Model /bulliResponsible 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. /liliResponsible for executing and implementing assessment tools reviewing the qualification and validation of conveyed IT GxP systems: Manufacturing, Lab, RD, Infrastructure, IT tools, Websites, Mobile Applications, Software as a Medical Device (SAMD), Supply Chain. /liliResponsible for executing and implementing the strategy for divesting IT Systems as part of a brand or company separation project. /liliProvides strategic direction and operational support to the individual project teams. /liliEnsures/promotes early involvement of TQC in the design and development of applications and infrastructure to ensure that automated and preventive controls are built in. /liliManages the end-to-end quality process and strategies for building and execution of applications and supporting infrastructure. /liliResponsible for implementing and maintaining TQ acquisitions and divestitures metrics and reporting for TQ infrastructure, application, healthcare AD activities such as assessments, integration, separation, and remediation. /liliTranslates the TQ Acquisition and Divestiture strategy into functional operational plans and ensures consistency for the Global TQ organization. /liliContributes to the creation of strategies for the qualification and validation of new and emerging technologies. /liliProvides compliance guidance and support to the project teams to ensure successful delivery of the project end-to-end. /liliEnsures 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 TQC portfolio. /liliParticipates in audits, approves audit non-conformity action plans, and approves closure of internal audit findings. /liliAssists with incident management/CAPA and NC for the systems supported. /liliManages the execution of TQ tasks according to the project plan, goals and timelines. /liliSupports the allocation of resources by accurately communicating availability. /liliResponsible for managing resources (both internal and external) and ensures availability for ongoing and upcoming initiatives/projects. /liliPerforms 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. /liliProactively monitors systems and processes to ensure compliance with standard operating procedures and industry best practices. /liliTracks and documents quantifiable business results achieved from project work and writes success stories for publication that demonstrate the business value created by TQC. /liliAbility to identify potential opportunities to automate SDLC tasks (e.g. AI, RPA etc.). /li /ul /lilibStakeholder Management /bulliRecognizes and responds to stakeholder needs and ensures commitments are delivered upon. /liliProvides partnership, insight and direction to cross-functional business leaders and stakeholders regarding TQ policies, solutions and initiatives. /liliBuilds 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. /liliManages relationships with the TQC 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). /liliManages relationships with Regulatory Compliance, Business Quality Operations and Business Quality Assurance, JJ Technology, RD Quality, Information Security Risk Management, Worldwide Records Information Management, Privacy, etc. for the AD business segment, globally. /li /ul /lilibRisk Management /bulliApplies comprehensive risk management approaches and Quality and Compliance Principles to address and propose mitigating for risks associated with acquisitions and divestitures, including due diligences. /liliUtilizes 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). /liliDefining overall validation and test strategies for acquiring systems, monitor risks throughout the execution, implement/test mitigations and/or workarounds. /liliProactively monitors/uncover any potential risks and partners with stakeholders on potential solutions; adopt quality processes (such as NC/CAPA) for deviations and defect management. /li /ul /lilibProject Management /bulliProactively partner with AD office to understand plan support for projects in the pipeline, clean sheet resources, engage with due diligence. /liliManage the initiative’s overall scope and schedule, while setting and aligning expectations. /liliAs a Power User, ensures that all Technology Quality related projects go through the Intake process manage budgets/resources to effectively deliver value to business. /liliEstablish clear communication channel up/down within and outside of the organization, e.g. with TQ LT Power User community. /liliDevelop/Leverage internal partnership for seamless transition of acquired/divested systems. /liliWork with AD Office in optimizing the Playbook. /li /ul /li /ulh3Qualifications and Requirements /h3ulliA 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. /liliA 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. /liliStrong ability to work effectively in a highly matrixed, global team environment. /liliStrong ability to effectively and productively communicate with external and internal stakeholders. /liliStrong cross-boundary collaboration, interdependent partnering, and influencing skills. /liliAbility to make decisions by building and maintaining trusting, collaborative relationships to meet business needs. /liliProven ability to lead people and guide them through change in a complex environment. /liliAbility to inspire trust and quickly build credibility. /liliExcellent listening skills with the ability to incorporate diverse perspectives. /liliStrong learning agility; demonstrates ability and willingness to continuously learn and remain current in the marketplace. /liliStrong problem‑solving skills to maintain project progress and resolve design issues. /liliStrong executive presence, communication, and facilitation skills. /liliStrong decision‑making abilities, including decisions on quality, compliance, and management matters. /liliStrong analytical skills. /liliAbility to quickly understand the business being integrated or separated and related processes. /liliFinancial acumen with understanding of how services contribute to cost and/or revenue. /liliAdvanced project and portfolio management skills. /liliStrong project management, planning, and organizational skills. /liliStrong customer‑centric mindset, with a focus on stakeholder needs and delivering service excellence (especially for new personnel during acquisitions). /liliHigh level of proactivity and resourcefulness in problem‑solving. /liliApplies design‑thinking methodology with a focus on end‑user solutions. /liliStrong teamwork and ability to drive toward common goals. /liliAbility to work effectively in a virtual team environment. /liliStrong experience in computerized system validation (CSV) in GxP environments within the pharmaceutical industry. /liliStrong understanding of data analytics and insights. /liliWorking knowledge of cGMP regulations related to CSV, including 21CFRPart11, Part210, Part211, Part820, and Annex11. /liliWorking knowledge of PMO, SDLC, GAMP5, and ITIL frameworks. /liliStrong mastery of quality‑related competencies, including Quality Strategy, Applications Infrastructure, Data Integrity, Testing, and Quality Management Systems. /liliAdvanced knowledge of security‑role design and segregation of duties. /liliFamiliarity with cybersecurity and privacy principles as they relate to quality and risk management. /liliUnderstanding of global and regional GxP regulations. /liliExperience with technology risk assessments. /li /ulh3Salary /h3pThe anticipated base pay range for this position is: €96,000.00 – €165,025.00. /ph3Benefits /h3ulliAn 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. /liliVacation days. /liliParental leave for a minimum of 12 weeks. /liliBereavement leave. /liliCaregiver leave. /liliVolunteer leave. /liliWell‑being reimbursement. /liliPrograms for financial, physical and mental health. /liliService anniversary and recognition awards. /liliEligibility for various insurance plans (employer and some location‑eligible dependents). /li /ul /p #J-18808-Ljbffr