Position: Senior Digital Transformation & IT Compliance Consultant
Location: Basel, Switzerland (with regional & international 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 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 (SAP S/4 HANA), and OT system onboarding projects, and establish quality and validation frameworks that uphold regulatory and cybersecurity standards and best practices.
Key Accountabilities
Digital Transformation & OT Systems Integration
- Lead digital transformation projects across manufacturing, lab, and engineering operations with a focus on Industry 4.0 and ISA95 understanding.
- Drive ERP transformation programs with a focus 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, Swissmedic, TGA).
- Provide expert guidance on regulations such as 21 CFR Part 11, EU Annex 11, ISO 13485, and ICH Q7/Q9.
Computerized System Validation & Strategy
- Lead the validation of complex IT-enabled GxP-regulated systems, including Technical Operations, SAP ERP, and Digital Finance systems.
- Implement Computer Software Assurance approaches to improve efficiency and scalability in validation.
- Provide validation expertise for greenfield projects, including custom MES solutions, ERP systems, and manufacturing control systems.
- Oversee the design and execution of validation protocols, test scripts, and traceability documentation.
Information Security & Risk Management
- Implement IT/OT security frameworks to safeguard 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 complex 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 a domain SME for large-scale RFPs, supplier audits, and global program governance.
- Provide guidance and mentorship to teams on compliance, cybersecurity, and validation practices.
Key Qualifications
Education & Languages
- Bachelor’s or Master’s degree in Pharmaceutical Sciences, Engineering, or Information Technology.
- Fluent in English, written and spoken; additional languages are a plus.
Experience & Technical Skills
- At least 15 years of experience in the Life Sciences sector, covering Medical Devices, Biopharma, and Pharmaceuticals.
- Proven leadership in IT and OT Quality Management Systems, including system onboarding, validation, and compliance in regulated global environments.
- Solid experience in managing cybersecurity and Information Security in OT landscapes, including network segmentation, secure device management, and incident response.
- Extensive expertise with MES, LIMS, QMS, and ERP solutions, including SAP S/4HANA and complex data migrations.
- 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.
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.
Your Profile
- Driven by impact, passionate about shaping the future of Life Sciences and healthcare through technology and innovation.
- Belief in open communication, speaking up, and engaging in meaningful discussions, even with leadership.
- Focus on solutions, taking a proactive approach to seeking improvements.
- Ownership of your work, taking responsibility and accountability seriously.
- Commitment to excellence, delivering high-performance results while embracing sustainable practices.
Our Culture
- Strive to be the best; we aim to be the world’s leading consulting company, empowering diverse talent to reach their full potential.
- Cultivate a culture of respect, valuing integrity, fairness, and unique contributions.
- Embrace mistakes as opportunities, learning from challenges.
- Prioritize potential over experience, valuing intelligence, values, and growth.
Contact
If you are driven, innovative, and eager to make an impact in Life Sciences consulting, we would love to hear from you. Apply online using the form below. Only applications matching the job profile will be considered.
Your KVALITO Team.