Senior Digital Transformation

Senior Digital Transformation & IT Compliance Consultant Life Science Consultant, Senior Digital Transformation & IT Compliance Consultant Position: Senior Digital Transformation & IT Compliance ConsultantLocation: Basel, Switzerland (with regional & internationally travel up to 50%)Workload: Full‑time (100%)Start Date: Immediately Mission: As a Senior Digital Transformation & IT 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 high‑impact leadership role supports regulated Life Sciences organisations in designing, implementing and managing compliant, secure, scalable systems across manufacturing, laboratory, supply chain and enterprise environments. Partner with client stakeholders to define strategy, guide complex ERP (SAP S/4 HANA) and OT system onboarding projects and establish quality and validation frameworks in adherence with regulatory and cybersecurity standards. Key Accountabilities Digital Transformation & OT Systems Integration Lead digital transformation projects across manufacturing, lab, and engineering operations with a focus on Industry 4.0, ISA95 understanding. Drive ERP transformation programs focusing on SAP S/4HANA, managing data migration, system validation and integration with OT and QMS environments. Ensure seamless IT/OT convergence, managing cross‑functional dependencies between infrastructure, cybersecurity and regulated processes. Support smart manufacturing initiatives, including digital twins, connected devices and integrated automation platforms. Quality Management & Regulatory Compliance Establish and maintain regulatory‑compliant QMS frameworks for both IT and OT landscapes. Develop and enforce processes for risk management, change management, deviations, investigations and CAPA implementation. Support readiness for global health authority inspections (FDA, EMA, Swissmed, TGA). Provide expert guidance on regulations such as 21 CFR Part 11, EU Annex 11, ISO 13485, and ICH Q7/Q9. Computerised System Validation & Strategy Lead the validation of complex IT‑enabled GxP‑regulated systems, including Technical Operations, SAP ERP and Digital Finance systems and interfaces. Implement Computer Software Assurance approaches to increase efficiency and scalability in validation. Provide validation expertise for green‑field projects, including custom MES solutions, ERP systems and manufacturing control systems. Oversee design and execution of validation protocols, test scripts and traceability documentation. Information Security & Risk Management Implement IT/OT security frameworks to protect GxP and SOX‑relevant systems. Conduct security risk assessments for high‑risk regulated systems. Collaborate with IT security teams to enforce network segmentation, secure configurations and threat mitigation strategies. Ensure secure onboarding and operation of functional devices and enterprise platforms. Stakeholder Leadership & Business Partnering Act as a trusted advisor to senior stakeholders, translating technical requirements into actionable business strategies. Lead cross‑functional workshops and training sessions to upskill internal teams and align them with regulatory and digital transformation goals. Serve as domain SME for large‑scale RFPs, supplier audits, and global programme governance. Provide guidance and mentorship to teams on compliance, cybersecurity and validation best practices. Key Qualifications Education & Languages: Bachelor’s or Master’s in Pharmaceutical Sciences, Engineering or Information Technology. Fluent in English, written and spoken, other language(s) a plus. At least 15 years experience in Life Sciences, covering medical devices, biopharma and pharmaceuticals. Proven payment in IT and OT-QMS systems, including onboarding, validation and compliance in regulated global environments. Solid experience in managing cyber & information security in OT landscapes, including network segmentation, secure device management and incident response. Extensive expertise and hands‑on with MES, LIMS, QMS and ERP, including SAP S/4HANA and complex data migrations. Smart manufacturing and Industry 4.0 environments. Managing green‑field facility setups and global digital transformations. Hands‑on knowledge of digital validation tools (e.g., Kneat, X‑Ray, ValGenesis) and wide 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. Core Competencies & Mindset Strategic thinker with the ability to connect business needs to technical solutions. Exceptional presentation and communication skills to engage senior leadership and global teams. Strong project leadership and program management capabilities for strategic cross‑functional initiatives. Problem‑solving mindset focused on risk mitigation and continuous improvement. Use the opportunity to drive impact, shape life science and healthcare through technology and innovation. Belief in open communication, speaking up and engaging in meaningful discussions, even with leadership. Focus on solutions rather than problems, proactive approach, continuous improvement. Own your work, take responsibility and accountability seriously, no matter how challenging the situation. Commit to excellence, delivering high‑performance results while embracing sustainable practices in everything you do. Strive to be the best; our mission is to become the world’s leading consulting company, empowering high‑performing individuals regardless of background to reach their full potential and leaving a lasting legacy of diversity, equality, inclusion, and excellence. Foster a culture of respect, value integrity, fairness, and the unique contributions of every team member. See mistakes as opportunities, embrace challenges, learn from them and continuously improve. Prioritize potential over experience, believe intelligence, values, and growth over the number of years. Contact: be driven, innovative, and eager to make an impact in Life Sciences consulting. Interested? Send your application to recruiting@kvalito.ch including CV, motivation letters, supporting documents. #J-18808-Ljbffr