IT Technical Regulatory Compliance Principal

Overview

Job Title: IT Technical Regulatory Compliance Principal

Department: Information Technology

Location: Remote, United States

Hours Per Week: 40

Schedule: Monday – Friday, Days

The IT Technical Regulatory Compliance Principal is responsible for leading and executing IT risk-based computer systems validation and associated technical compliance initiatives within ACM’s two core businesses: laboratory services and clinical trials research. These businesses operate under US FDA, UK MHRA, EMEA, GCP, GLP, laboratory and other regulations. This hybrid role combines technical hands-on computer systems validation and regulatory compliance execution.

The role ensures that IT systems—particularly ACM’s data center infrastructure at RRH, cloud-hosted and SaaS applications, laboratory equipment, LIMS systems —are implemented, validated, and maintained in accordance with regulations (21 CFR Part 11, Part 820, ICH, OECD 22), GLP, GCP requirements, and company policies and procedures. This role will be the IT CSV department’s key resource for representing IT in internal, customer, and regulatory audits, observations response and all follow-up for observations, quality events and CAPA’s.

Managing the relationship with the Quality function is paramount to being successful here. The role will oversee the IT CSV Change Management process and be a member of the Change Approval Board.

• Lead IT compliance initiatives ensuring adherence to world-wide regulatory authorities, GLP, GCP, and other applicable regulations and standards (e.g., 21 CFR Part 11, 820, Annex 11, OECD 22).
• Manage and execute validation of cloud-based and hosted applications, including risk assessments, validation planning, IQ/OQ/PQ testing, and traceability documentation.
• Primary owner of the system development lifecycle and CSV process and policies and procedures for such.
• Oversee the new system implementation process and IT change management process.
• Develop, review, and maintain key compliance and SDLC documents such as validation protocols, test scripts, SOPs, configuration management, change control, and system release documentation.
• Prepare and lead IT-related activities for FDA, UK, EU and other regulatory inspections or audits; provide expert responses to auditor queries; manage quality events, corrective and preventive actions (CAPAs) resulting from inspections.
• Author and maintain IT compliance policies, procedures, and standard operating procedures (SOPs) to ensure consistent, regulatory-aligned practices across systems and teams.
• Partner with IT infrastructure, cybersecurity, QA, and business system owners to ensure alignment of compliance and validation activities with business needs.
• Evaluate and enhance IT validation and compliance processes for efficiency and scalability in support of digital transformation and cloud adoption.
• Take Quality ownership, participate in cross-functional team discussions, provide quality guidance/decisions for the projects that include new implementation, enhancements, quarterly releases, periodic reviews, review and approve Quality events (deviations & CAPS), etc.
• Participate and drive system assessments, review and approve the project deliverables, including plan, test scripts, execution and its outcome, reports, and traceability.
• Actively participate in and guide discussions to resolution, adhering to all quality standards.

• Bachelor degree in computer science.
• 10 years experience in life sciences computer systems validation (biotech, pharma, medical device, laboratory services).
• Five years employment in a lab services environment.
• Five years in a biotech, pharma or device environment.

• Detailed knowledge of IT infrastructure equipment, utilities and supporting processes and computerized system validation concepts for such; including servers, HVAC, physical security, virtual security, fire detection and protection, network architecture and layers.
• International Society of Pharmaceutical Engineers (ISPE) GAMP 5 training or equivalent experience.
• Familiarity with IT Infrastructure Library (ITIL), IT as-a-service Change process, service level…