149 applicants

Company

Nestlé Health Science · 2 days ago

IT Compliance Expert - GxP (Remote)

Brisbane, CA

Full-time

Remote

Senior Level

$120K/yr - $160K/yr

7+ years exp

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Responsibilities

Partner with business partners to select, plan, design, install, and validate IT GxP Systems in alignment with industry best practices (e.g., CSA) and NHSc SOPs and Policies.

Establish and drive governance processes that oversee and deliver critical GxP IT projects and operations.

Collaborate with Nestle IT and business partner leadership to develop the technology strategy, budget, and roadmap for NHSc IT GxP Systems.

Provide implementation and technical consultation of new GxP systems to support NHSc product portfolio.

Serve as Project Manager for technology implementations, including coordination and management of external vendors and ensuring adherence to corporate GxP SOPs.

Manage relationships with vendors and external service providers, ensuring high-quality service delivery and escalation of challenging issues when appropriate.

Support Clinical Operations, Biometrics, and data management systems to ensure IT GxP compliance.

Oversee application lifecycles for enterprise GxP IT systems, collaborating with business partners, to ensure effective change control, testing, validation, and communication.

Act as a subject matter expert for the IT GxP Compliance Program.

Partner with QA to manage systems validation, periodic reviews, and vendor coordination.

Lead or support deviation/incident investigations related to corporate GxP information systems and manage the implementation of identified Corrective Actions/Preventive Actions (CAPA) resulting from these investigations.

Support as needed in external/internal audits and inspections.

Responsible for managing changes to IT GxP systems and supporting processes.

Develop and lead a high-performing team of information technology professionals, fostering a culture of collaboration and support through coaching and mentoring.

Successfully translate business requirements into team deliverables, individual goals, and objectives.

Develop and measure IT support metrics and implement continuous improvement processes and procedures.

Prepare operational forecasts and requirements, including monthly reports and budget analyses.

Ensure compliance with application services standards, procedures, documentation requirements, and policies.

Drive continuous improvement in system performance and service quality for GxP applications.

Develop detailed project tasks, milestones, status reports, and other project documentation to ensure timely and on-budget delivery of projects.

Ensure compliance with SOPs (Standard Operating Procedures) and WIs (Work Instructions) and documentation standards.

Ensure regulatory compliance is aligned with industry best practices and standards.

Support the organization in maintaining a work environment focused on quality and that fosters learning, respect, open communication, collaboration, integration, and teamwork.

Perform other responsibilities as assigned or needed.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

GxP IT systemsProject ManagementVeevaServiceNowSASClinical Data ManagementBiotech Project ManagementCAPARegulatory ComplianceSoftware as a Service (SaaS)Change ControlTechnical DocumentationCustomer Service Orientation

Required

BS degree in computer science, information technology, or equivalent work experience.

7+ years of experience supporting enterprise GxP IT systems, with experience in the following: IT biotech project management experience in a multinational environment.

Deep understanding of biotech/pharmaceutical manufacturing systems and processes supporting drug safety, pharmacovigilance, manufacturing, engineering automation, regulatory compliance, quality management and compliance, medical information, or clinical trials applications.

IT working knowledge in a biotech research lab environment, familiar with lab systems implementation and system requirements, clinical operations.

Knowledge of systems software, operations, capacity management, mid-range servers, PCs, SAAS, and web services. Must have hands-on experience in qualifying production servers to meet regulatory requirements.

Knowledge and expertise with Software as a Service (SaaS) systems, automated process equipment, and clinical data management software in the biotechnology or pharmaceutical industry.

Experience with Veeva RIMS, QMS, QDocs, SAS, PleaseReview, LabVantage LIMS, ServiceNow, DocuSign Part 11, Clinical Data Repository, Electronic Notebooks solutions highly desirable.

Experienced in risk assessments, remediation plans, and corrective and preventive action (CAPA), and in reviewing, modifying, and writing standard operating procedures (SOPs).

Technical documentation such as VP, IQ, OQ, Test Protocols, Summary reports.

Solid applied knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, Part 820, Annex 11, and GAMP 5, CSA, Data Integrity.

Experience managing change control processes.

Must possess excellent communication skills with the proven ability to interface and influence at all levels in the organization.

Must be detail-oriented with strong analytical, organizational, and problem-solving skills.

Ability to troubleshoot, research, and solve technically challenging problems involving integrated systems.

Strong customer service orientation and an understanding of business processes related to pharmaceutical and dietary supplement manufacturing.

Occasional travel required, as needed.