YASH Technologies is Hiring - IT Risk and Vendor Compliance Lead

Job description: Experience required : 8+ years IT Risk and Vendor Compliance Lead Role Summary This role is responsible for establishing, maintaining, and continuously improving the companys IT quality, risk, and vendor compliance framework. This role ensures that IT systems and thirdparty vendors supporting regulated processes are fit for intended use, compliant with regulatory requirements, and aligned with quality and data integrity expectations. The role works in close partnership with Information Security (InfoSec) to ensure technology risks are appropriately identified, assessed, and managed across quality, security, and compliance domains, while maintaining clear ownership boundaries between Quality and Security responsibilities. Key Responsibilities IT Risk Management Lead the identification, assessment, and mitigation of IT and technologyrelated risks, including GxP, data integrity, cybersecurity, and operational risks. Define and maintain a riskbased approach to IT governance aligned with applicable regulations and standards (e.g., FDA QMSR, 21 CFR Parts 11 and 820, ISO 13485, ISO 27001, Annex 11). Support system risk assessments for new tools, enhancements, upgrades, and decommissioning activities. Lead IT system and vendor risk assessments from a quality and regulatory perspective. Ensure risks impacting GxP compliance, data integrity (ALCOA+), and patient/product safety are properly assessed and mitigated. Vendor and ThirdParty Compliance Lead vendor risk assessments, due diligence activities, and ongoing monitoring for critical and highrisk vendors. Partner with InfoSec to align vendor quality risk assessments with: Security risk assessments Data classification and data flow analyses Review and assess vendor documentation, including: Quality Management Systems (QMS) SOC reports Validation and assurance documentation Coordinate and participate in vendor audits, as required. Partnership with Information Security Work closely with InfoSec to ensure data protection, privacy, and cybersecurity controls support regulatory requirements Review system architectures, data flows, and data classifications affecting regulated data Collaborate to ensure security controls are implemented and operated in a manner that supports regulatory compliance, audit readiness, and data integrity. Collaborate with Information Security to develop, maintain, and improve IT risk, vendor compliance, and thirdparty governance procedures as appropriate. Audit, Inspection, and Issue Management Support internal audits, regulatory inspections, and thirdparty assessments related to IT systems and vendors. Support CAPA development and remediation activities related to IT risk or vendor findings. CrossFunctional Leadership and Influence Partner closely with IT, Quality, InfoSec, and Business teams to enable compliant technology adoption. Provide practical, riskbased guidance that supports business needs while maintaining regulatory compliance. Communicate complex compliance and risk concepts clearly to nontechnical stakeholders. Required Qualifications Bachelors degree in Information Technology, Computer Science, Engineering, Quality, or a related field 8+ years of experience in IT Quality & Compliance, IT Risk Management or Vendor Oversight within a regulated environment (pharma, biotech, medical devices, or similar) Strong working knowledge of: FDA QMSR / 21 CFR Part 820 21 CFR Part 11 ISO 13485 and ISO 9001 Data Integrity principles (ALCOA+) Handson experience supporting vendorhosted and SaaS systems in GxP contexts. Experience leading or supporting vendor audits. Familiarity with information security frameworks (e.g., ISO 27001, SOC 2). Experience working with cloudbased systems and modern IT delivery models Demonstrated experience partnering with Information Security teams. Preferred Qualifications Professional certifications (e.g., CISA, CISSP, CRISC, ASQ, ISPE) a plus.