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

$154,116 - $170,000/Yr

Nevro - Redwood City, CA

Full-time - Mid Level

Remote - Redwood City, CA

Computer and Electronic Product Manufacturing

About the position

The IT Compliance/Validation Manager at Nevro Corp is responsible for overseeing all aspects of IT compliance, testing, and system/software changes. This role involves managing the Computer System Validation (CSV) Programs and ensuring compliance with internal controls related to Sarbanes-Oxley. The manager will apply their expertise in GxP, CSV, SOX, ITGC, and FDA regulations to enhance IT delivery services and maintain quality standards in a regulated environment.

Responsibilities

• Manage IT's Computer System Validation (CSV) Programs and Risk, and Compliance management of IT operations.
• Coordinate internal/external audit resources with IT and manage Nevro's Change Management Process (CMP) and Change Advisory Board (CAB).
• Develop testing strategy across IT applications for GxP and non-GxP applications.
• Maintain IT's Computer Validation System (CVS) SOP and lead validation efforts related to new and existing applications.
• Perform validation activities throughout the validation life cycle, including developing documentation evidence and managing/executing protocols.
• Conduct IT delivery services, process improvements, and assessment of IT control environment.
• Manage/coordinate validation project activities through project phases and ensure completion of validation tasks.
• Support manufacturing systems validation, including MES and ERP.

Requirements

• 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.
• Experience performing IT quality and compliance in an FDA-regulated environment (GxP).
• Experience working with CSV, 21 CFR Part 11, and ITIL frameworks as related to IT delivery services.
• Experience in development and review of IT and Quality SOP's.

Nice-to-haves

• Experience in strategic planning validation activities for projects related to IT applications.

Benefits

• Competitive salary range of $154,116-170,000/year.
• Equal employment opportunity regardless of various protected characteristics.