Senior Digital Transformation, and IT Quality & Compliance Consultant

Role Description
As 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/4 HANA), OT system onboarding projects and establish quality and validation frameworks upholding the regulatory and cybersecurity standards and best practices.

Key Responsibilities

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.
•Lead 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.
•Ensure alignment with Annex 1, GAMP 5, ISPE guidance, and global GMP expectations for aseptic manufacturing environments.

Quality Management & Regulatory Compliance
•Establish and maintain regulatory-compliant QMS frameworks for IT, OT, Medical devices, and SaMD 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, ISO14971, IEC62304 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 improve efficiency and scalability in validation.
•Provide validation expertise for greenfield 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 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.

Pre-Sales, Business Development & Subject Matter Expertise
•Support business growth by identifying, qualifying, and developing opportunities with new Life Sciences clients (new logos), particularly within OT Digital Transformation, CSV, Quality & Compliance.
•Act as the Subject Matter Expert (SME) during pre-sales engagements, discovery workshops, solution design, proposal development, client presentations, and technical bid defenses.
•Contribute to RFP/RFI responses, solution architecture, effort estimation, and commercial value propositions in collaboration with sales and delivery teams.
•Build trusted executive relationships and provide strategic consulting that positions the organization as a preferred transformation partner.

Stakeholder Leadership & Business Partnering
•Actas 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.
•Higher Education in Operations in a plus.
•Fluent in English, written and spoken, any other language is a plus.

Experience:
•At least 15 years of blended experience working in IT services handling particularly 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 cyber, and Information security in OT landscapes, including network segmentation, secure device management, and incident response.

•Extensive experience with:
oMES, LIMS, QMS, and ERP solutions, including SAP S/4HANA and complex data migrations.
oSmart Manufacturing and Industry 4.0 environments.
oManaging greenfield facility setups and global digital transformations.
oHands-on experience with digital validation tools (e.g., Kneat, X-Ray, ValGenesis) and exceptional Regulatory & Technical Knowledge
oDeep 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 with a focus on risk mitigation and continuous improvement.