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Rochester Regional Health · 17 hours ago

IT Technical Regulatory Compliance Principal

Rochester, NY

Full-time

Onsite

Senior Level, Lead/Staff

$105K/yr - $150K/yr

10+ years exp

Rochester Regional Health is seeking an IT Technical Regulatory Compliance Principal responsible for leading IT risk-based computer systems validation and regulatory compliance initiatives. The role involves ensuring that IT systems are implemented and maintained in accordance with various regulations, and managing the relationship with the Quality function is crucial for success.

Health CareHospitalMedicalPrimary and Urgent CareWellness

Responsibilities

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

Qualification

Computer Systems ValidationRegulatory ComplianceGxP RegulationsValidation PlanningIT Infrastructure KnowledgeISPE GAMP 5 TrainingCloud Applications ValidationTechnical WritingCommunication SkillsProblem-Solving SkillsTeam PlayerLeadership Skills

Required

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

Preferred

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)

Well versed in writing standard operating procedures, work instructions, and the full complement of ISPE GAMP 5 CSV documents for GAMP Category 4 and 5 systems

Sound knowledge of and Embrace Data Integrity integral to the system projects

Should possess good communication skills and fit well as a team player

Exceptional communication and leadership skills. Ability to present in front of Executives

Strong analytical, problem-solving, and organizational abilities

Comfortable operating in a fast-paced, highly regulated, changing environment

Demonstrated competence and completion of migrating CSV to Computer Software Assurance (CSA) processes