Senior Digital Transformation & IT Compliance Consultant / Senior Digital Transformation & IT Compliance Consultante

Life Science Consultant, Senior Digital Transformation & IT Compliance Consultant

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 position supports regulated Life Sciences organizations by designing, implementing, and managing 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, focusing on Industry 4.0 and ISA95 understanding.
• Drive ERP transformation programs centered on SAP S/4 HANA, overseeing data migration, system validation, and integration with OT and QMS environments.
• Ensure seamless IT/OT convergence, managing cross-functional dependencies among 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).
• Offer 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 and interfaces.
• Implement Computer Software Assurance approaches to enhance 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 the 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, both 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.
• Strong experience in managing cyber and information security in OT landscapes, including network segmentation, secure device management, and incident response.

Extensive Expertise

• Hands-on experience with MES, LIMS, QMS, and ERP solutions, including SAP S/4 HANA and complex data migrations.
• Experience in Smart Manufacturing and Industry 4.0 environments.
• Proven capability in managing greenfield facility setups and global digital transformations.
• Proficient with digital validation tools (e.g., Kneat, X-Ray, ValGenesis) and possess exceptional regulatory and 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 adept at connecting 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.

You

• Are driven by impact and passionate about shaping the future of Life Sciences and healthcare through technology and innovation.
• Believe in open communication, speak up, challenge ideas, and engage in meaningful discussions, even with leadership.
• Focus on solutions, taking a proactive approach to improvement rather than assigning blame.
• Own your work, taking responsibility and accountability seriously, regardless of the challenges.
• Commit to excellence, delivering high-performance results while embracing sustainable practices in all endeavors.

We

• Strive to be the best; our mission is to become the world’s leading consulting company, empowering high-performing individuals to reach their full potential and leave a lasting legacy of diversity, equity, inclusion, and excellence.
• Foster a culture of respect, valuing 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, believing that intelligence, values, and growth matter more than how many years are on a résumé.

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.

Please note that only applications matching the job profile will be considered.

Your KVALITO Team.