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Company

Nevro · 21 hours ago

IT Compliance/Validation Manager (Redwood City, CA Onsite)

Redwood City, CA

Full-time

Remote

Mid, Senior Level

$154K/yr - $170K/yr

5+ years exp

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Responsibilities

Responsible for all aspects of IT compliance, testing, and system/software changes.

Manage IT’s Computer System Validation (CSV) Programs and Risk, and Compliance management of IT operations that address Internal Control over Sarbanes-Oxley.

Apply knowledge and experience in GxP, CSV, SOX, ITGC, 21 CFR Part 11, and ITIL frameworks related to IT delivery services.

Perform Software Development Life Cycle (SDLC) or relevant framework.

Coordinate internal/external coordination audit resources with IT, while also managing Nevro’s Change Management Process (CMP) and Change Advisory Board (CAB).

Develop testing strategy across IT applications for GxP and non GxP applications.

Coordinate with appropriate groups (executive management, internal audit, external audit, etc.) regarding regulatory changes and industry standards and manage a team including direct reports and consultants.

Maintain IT’s Computer Validation System (CVS) SOP and lead validation efforts related to new and existing applications by working in partnership with key company stakeholders including Quality, Validation, Legal, Finance, and HR.

Apply understanding of computer system development process and FDA regulations to perform validation activities throughout validation life cycle, including developing documentation evidence, managing/executing protocols, initiating change procedures, and ensuring quality.

Perform IT quality and compliance in an FDA-regulated environment (GxP).

Design and execute validation strategy for implementation of new systems.

Conduct IT delivery services, process improvements, and assessment of IT control environment.

Understand company software systems to navigate system to analyze test results.

Manage/coordinate validation project activities through project phases.

Develop validation documents like plan and summary reports in alignment with internal procedures.

Oversee internal and external team members to execute validation activities.

Assess upcoming projects.

Support manufacturing systems validation, including MES and ERP.

Define and manage validation activities based on project.

Allocate tasks to internal and external team members.

Ensure generation of required validation deliverables like Validation plan, Test protocols, Test summary reports, Validation summary reports, etc. based on projects.

Define timelines validation/ test activities and define project timelines in collaboration with project management team.

Track and ensure completion of validation tasks by coordinating with team members.

Optimize resource utilization.

Train validation resources on process and procedures.

Manage direct employees and consultants.

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.

Software Development Life Cycle (SDLC)GxP complianceComputer System Validation (CSV)21 CFR Part 11ITIL frameworksIT delivery servicesProcess improvementsIT control assessmentQuality SOP developmentStrategic planningValidation EngineeringRegulatory AffairsTraining resourcesProject managementTeam management

Required

Bachelor's degree in Computer Science, Regulatory Affairs, Validation Engineering, or related field

5 years of progressive post baccalaureate experience as a validation engineer or regulatory specialist

5 Years Of Experience With Software Development Life Cycle (SDLC) or relevant framework

5 Years Of Experience Performing IT quality and compliance in an FDA-regulated environment (GxP)

5 Years Of Experience Working with CSV, 21 CFR Part 11, and ITIL frameworks as related to IT delivery services

5 Years Of Experience in IT delivery services, process improvements, and assessment of IT control environment

5 Years Of Experience in Development and review of IT and Quality SOP’s

5 Years Of Experience in Strategic planning validation activities for projects related to IT applications

Company

Nevro

Glassdoor

3.7

Nevro provides pain relief solutions for patients suffering from low back pain and other types of chronic pain. It is a sub-organization of Nevro.

Founded in 2006

Menlo Park, California, USA

1001-5000 employees

http://www.nevro.com

H1B Sponsorship

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Trends of Total Sponsorships

2023 (7)

2022 (21)

2021 (7)

2020 (11)