Senior Digital Transformation, and IT Quality & Compliance Consultant

ph3Senior Digital Transformation, and IT Quality Compliance Consultant /h3 pAs a Senior Digital Transformation, and IT Quality Compliance Consultant, you will play a pivotal role in leading digital transformation initiatives at the intersection of Operational Technology, Quality Management, Computerized System Validation, and Information Security. This is a high-impact leadership role supporting regulated Life Sciences organizations through the design, implementation, and management of compliant, secure, and scalable systems across manufacturing, laboratory, supply chain, and enterprise environments. You will partner with client stakeholders to define strategy, guide complex ERP (S/4HANA) onboarding projects and establish quality and validation frameworks upholding regulatory and cybersecurity standards and best practices. /p h3Key Responsibilities /h3 h3Digital Transformation OT Systems Integration /h3 ul liLead digital transformation projects across manufacturing, lab, and engineering operations with a focus on Industry 4.0 and ISA95. /li liDrive ERP transformation programs with a focus on SAP S/4HANA, managing data migration, system validation, and integration with OT and QMS environments. /li liEnsure seamless IT/OT convergence, managing cross‑functional dependencies between infrastructure, cybersecurity, and regulated processes. /li liSupport smart manufacturing initiatives, including digital twins, connected devices, and integrated automation platforms. /li liLead Operational Technology (OT) validation strategies covering Cleanroom Qualification, Utility Qualification (PW/WFI, Clean Steam, Compressed Gases, HVAC), Cleaning Validation, Sterilization Validation, and Sterility Assurance programs. /li liEnsure alignment with Annex 1, GAMP 5, ISPE guidance, and global GMP expectations for aseptic manufacturing environments. /li /ul h3Quality Management Regulatory Compliance /h3 ul liEstablish and maintain regulatory‑compliant QMS frameworks for IT, OT, Medical devices, and SaMD landscapes. /li liDevelop and enforce processes for risk management, change management, deviations, investigations, and CAPA implementation. /li liSupport readiness for global health authority inspections (FDA, EMA, Swissmedic, TGA). /li liProvide expert guidance on regulations such as 21 CFR Part 11, EU Annex 11, ISO 13485, ISO 14971, IEC 62304 and ICH Q7/Q9. /li /ul h3Computerized System Validation Strategy /h3 ul liLead the validation of complex IT‑Enabled GxP‑regulated systems, including Technical Operations, SAP ERP, and Digital Finance systems and interfaces. /li liImplement Computer Software Assurance approaches to improve efficiency and scalability in validation. /li liProvide validation expertise for greenfield projects, including custom MES solutions, ERP systems, and manufacturing control systems. /li liOversee design and execution of validation protocols, test scripts, and traceability documentation. /li /ul h3Information Security Risk Management /h3 ul liImplement IT/OT security frameworks to safeguard GxP and SOX‑relevant systems. /li liConduct security risk assessments for high‑risk regulated systems. /li liCollaborate with IT security teams to enforce network segmentation, secure configurations, and threat mitigation strategies. /li liEnsure secure onboarding and operation of functional devices and enterprise platforms. /li /ul h3Pre‑Sales, Business Development Subject Matter Expertise /h3 ul liSupport business growth by identifying, qualifying, and developing opportunities with new Life Sciences clients, particularly within OT Digital Transformation, CSV, Quality Compliance. /li liAct as the Subject Matter Expert during pre‑sales engagements, discovery workshops, solution design, proposal development, client presentations, and technical bid defenses. /li liContribute to RFP/RFI responses, solution architecture, effort estimation, and commercial value propositions in collaboration with sales and delivery teams. /li liBuild trusted executive relationships and provide strategic consulting that positions the organization as a preferred transformation partner. /li /ul h3Stakeholder Leadership Business Partnering /h3 ul liAct as a trusted advisor to senior stakeholders, translating complex technical requirements into actionable business strategies. /li liLead cross‑functional workshops and training sessions to upskill internal teams and align them with regulatory and digital transformation goals. /li liServe as a domain SME for large‑scale RFPs, supplier audits, and global program governance. /li liProvide guidance and mentorship to teams on compliance, cybersecurity, and validation practices. /li /ul h3Key Qualifications /h3 h3Education Languages /h3 ul liBachelor’s or Master’s degree in Pharmaceutical Sciences, Engineering, or Information Technology. /li liHigher Education in Operations is a plus. /li liFluent in English, written and spoken; other languages are a plus. /li /ul h3Experience /h3 ul liAt least 15 years of blended experience in IT services, particularly within the Life Sciences sector, covering Medical Devices, Biopharma, and Pharmaceuticals. /li liProven leadership in IT and OT Quality Management Systems, including system onboarding, validation, and compliance in regulated global environments. /li liSolid experience in managing cyber and Information security in OT landscapes, including network segmentation, secure device management, and incident response. /li liExtensive experience with MES, LIMS, QMS, and ERP solutions, including SAP S/4HANA and complex data migrations; smart manufacturing and Industry 4.0 environments; managing greenfield facility setups and global digital transformations; hands‑on experience with digital validation tools (e.g., Kneat, X‑Ray, ValGenesis) and exceptional Regulatory Technical Knowledge; deep expertise in global regulatory standards: 21 CFR Part 11, EU Annex 11, ISO 13485, ISO 14971, ISO 62304, ICH Q7/Q9, SOX. /li /ul h3Core Competencies Mindset /h3 ul liStrategic thinker with the ability to connect business needs to technical solutions. /li liExceptional presentation and communication skills to engage senior leadership and global teams. /li liStrong project leadership and program management capabilities for strategic, cross‑functional initiatives. /li liProblem‑solving mindset with a focus on risk mitigation and continuous improvement. /li /ul h3Work location /h3 p6301 Zug (ZG) /p h3Additional information on the place of work /h3 pHybrid model – Basel and Home /p h3Workload /h3 p100 % /p h3Employment start /h3 h3Employment duration /h3 pPermanent /p h3Work form /h3 pHome‑based work /p h3Qualification /h3 pskilled /p h3Work experience /h3 pMore than 3 years /p h3Education /h3 pMaster’s degree from a university of applied sciences or equivalent /p h3English /h3 pOrally : Very good knowledge ; Written : Very good knowledge /p h3Contact /h3 pBy email: br/By phone: +41 76 531 44 00br/By post: Eiza Techologies AGbr/Ibelweg 18abr/6301 Zug /p /p #J-18808-Ljbffr