About Our Company

Universal DX, Inc. is an international Company with a highly experienced team focused on cracking cancer’s code. Through our multi-omics and bioinformatics models, we have figured out how to read the disease’s signals in blood with high accuracy to detect cancer in its earliest stages. Starting with a colorectal cancer screening liquid biopsy test, we are building a multi-cancer platform that can identify the unique DNA regions associated with different types of cancers.

The Opportunity

Universal Dx is seeking a Director/Sr. Director of Information Technology to lead and scale a secure, reliable, compliant, and business-aligned IT function supporting enterprise operations, regulated laboratory and manufacturing environments, and company growth. This role is responsible for the strategy, governance, and operational management of enterprise IT systems, infrastructure, cybersecurity, cloud platforms, workplace technology, and regulated IT systems supporting CLIA laboratory operations, medical device development, manufacturing activities, and quality systems.

You will partner closely with Corporate Functions, Laboratory and Manufacturing Operations, Software Engineering, Bioinformatics, Quality Assurance, and Regulatory Affairs to ensure that IT systems and processes meet business needs while maintaining compliance with applicable regulatory requirements, including FDA, CAP/CLIA, ISO 13485, HIPAA, and GxP expectations.

This leader will establish and maintain scalable enterprise IT systems and processes, strengthen cybersecurity and operational maturity, support validated environments, and ensure appropriate governance, traceability, and control across both business and regulated systems. As part of the team, you will be in a Company that aims more than to become one of the leaders in the industry. We want to have a huge positive impact on society by achieving the ambitious purpose of “making cancer a curable disease by detecting it earlier”.

How You’ll Contribute

Develop and execute the company’s IT strategy, roadmap, and operating model aligned with business objectives and organizational growth
Lead enterprise IT operations across infrastructure, cloud services, networking, endpoint management, collaboration platforms, identity management, and service delivery
Establish scalable IT governance, operations processes, service management practices, and performance metrics
Define, evolve, and ensure availability, reliability, scalability, and security of enterprise systems and infrastructure
Oversee IT asset lifecycle management, including procurement, provisioning, inventory, support, maintenance, and decommissioning
Manage enterprise cybersecurity capabilities, including endpoint security, vulnerability management, monitoring, incident response, and business continuity
Establish and maintain disaster recovery, backup, and business continuity programs
Establish and enforce identity and access management (IAM), role-based access controls, and least-privilege principles across all systems
Manage third-party vendors and service providers to ensure security, reliability, and compliance requirements are met
Build, develop, and lead a high-performing IT organization, including hiring, developing, and managing a high-performing team

Regulated Laboratory and Manufacturing Responsibilities

Ensure IT systems and infrastructure supporting laboratory and manufacturing operations comply with applicable regulatory requirements, including FDA 21 CFR Part 11 and Part 820/QMSR, CLIA/CAP, ISO 13485, HIPAA, and applicable GxP requirements
Support regulatory inspections, submissions, audits, and quality management activities
Partner with Quality Assurance and Regulatory Affairs to maintain audit readiness, support validation, change control, and compliance activities for regulated systems
Establish and maintain IT policies, SOP standards, and documentation supporting regulated operations

Laboratory Systems, Manufacturing Systems & Data Integrity

Oversee IT systems supporting CLIA/CAP laboratory operations and manufacturing operations including laboratory instruments, LIMS, data storage, and supporting infrastructure
Ensure proper segregation and governance between regulated systems and general corporate environments. Ensure controlled and secure connectivity between enterprise, laboratory, and manufacturing systems.
Implement and maintain controls supporting data integrity, traceability, auditability, and secure electronic records
Ensure appropriate logging, monitoring, access control, backup, retention, and recovery processes for regulated systems
Support SW Engineering and Lab Operations on computerized system validation (CSV) / computer software assurance (CSA) activities for GxP-relevant systems and infrastructure impacting product quality or regulated operations
Ensure controlled management of system changes, patches, upgrades, and configurations in validated environments
Maintain processes for user access reviews, role-based access controls, least-privilege principles, and privileged account management
Support Lab Operations on lifecycle management of laboratory systems, including qualification, maintenance, change control, periodic review, and retirement
Coordinate with laboratory operations and quality teams to minimize operational risk and downtime for critical systems

What You’ll Bring

Bachelor’s degree in Information Technology or related field, or equivalent experience
10+ years of IT leadership experience, including experience in regulated healthcare, biotech, medical device, diagnostics, pharma, or laboratory environments
Proven ability to build, scale, and lead enterprise IT operations, infrastructure, cybersecurity, and service delivery functions
Proven ability to establish IT governance, operational processes, and scalable infrastructure in growing organizations
Experience supporting multi-site or hybrid environments, including laboratory, clinical, logistics, or operational settings
Experience developing and implementing IT policies, procedures, and compliance frameworks
Strong understanding of security principles, risk management, data integrity, access control, audit trails, electronic records, data protection, and compliance-related IT controls
Strong knowledge of / experience on regulated environments and applicable standards, including FDA, CLIA, ISO 13485, HIPAA, and GxP principles.
Experience supporting audits, inspections, or compliance programs in healthcare, biotech, or medical device environments preferred
Strong leadership, communication, stakeholder management, and cross-functional collaboration skills, with ability to align IT strategy to business, product, and laboratory objectives.

What We´ll Offer

We’re proud to offer exceptional corporate benefits which include:

Flexible work schedule
A global family assistance policy with paid time off following the birth or adoption of a child
Accrued time off
Company-sponsored benefit plans which include Paid Time Off, Medical, Dental, Vision, 401(k)
Free day on your birthday
Possibility to buy extra vacation days
And more to come….

Why Now?

This is an exciting time to be at Universal DX. We are growing rapidly and starting our US operations by building up our team, starting our lab and business operations, and establishing strategic partnerships.

We are looking for passionate changemakers to be a part of our journey in this expansive time for us.

Universal Diagnostics S.A.

Vacatures

Director of IT