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.

Requirements

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 agreements, some project management experience.
10 years of experience validating hosted, cloud GxP applications under International Society of Pharmaceutical Engineers (ISPE) Good Automated Manufacturing Processes (GAMP 5) methodology.
10 years of experience developing typical GAMP 5 deliverables such as validation plans, functional requirements, user requirements, system design documents, configuration specifications, OQ test scripts, PQ/UAT test scripts, requirements traceability matrix, validation summary reports, supporting SOP’s, work instructions.
10 years of experience supporting technology, software and systems in US FDA regulated environment, UK MHRA, EMEA environments and regulations.
Expert in 21 CFR Part 11, Part 820, OECD 22, GLP, GCP.
5 years of experience supporting worldwide regulatory inspections and direct inspector involvement.
Deep understanding of on-premise data center, equipment, utilities, closets, servers, power, HVAC, lab instrumentation, lab utilities, interfaces to LIMS systems, GxP, 21 CFR Part 11, Annex 11, and CSV methodologies.
Strong documentation and technical writing skills.
Expert in using Microsoft Office tools and Sharepoint.
Familiarity with modern SDLC frameworks (Agile, DevOps) and change management systems.
Experience with cloud service providers (AWS, Azure) and enterprise applications (e.g. Veeva, Salesforce, ServiceNow).

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

computer systems validationrisk assessmentsvalidation planningIQ/OQ/PQ testingchange controlvalidation protocolstest scriptsconfiguration managementGxP applicationstechnical writing

Soft skills

quality ownershipcross-functional collaborationguidance and decision makingcommunicationproblem resolution

Certifications

Bachelor degree in computer scienceISPE GAMP 5 training