Software Quality & Compliance Manager (SQA)

Experience: 10+years

Job Location: Remote

Qualifications: B Tech / M Tech/ MCA or Higher

Work Timings: 1:30 PM IST to 10:30 PM IST

We are seeking a person with 10+ years of experience in driving the adoption of Integrated Management Systems (Quality Management Systems) across projects and support functions, with hands-on experience in creating awareness, reviewing artifacts with reference to applicable policies, processes, guidelines, checklists, and templates. The person must have valuable experience in ISO27001:2022, ISO9001:2015. Awareness and exposure of SOC2, HIPAA, and ISO42001 are mandatory as an integrated management system is based on required practices in context with the organization

Key Responsibilities

Lead the adoption of the Integrated Management System (Quality Management System, Information Security Management System, AI Management System) across projects and support functions

• Create awareness and training sessions across projects and support functions regarding applicable policies, processes, templates, guidelines, checklists, etc
• Proactively raise alerts if there are gaps or delays in the adoption of applicable policies and processes.
• Conduct release audits prior to release and provide recommendations, Go / No-Go
• Proactively plan call with respective stakeholders of the project and support functions, in case there are delays in adoption of applicable policies and processes. And, control risks related to adoption of policies and processes of the organization
• Review project artifacts and raise alerts in case of delays or deviations from approved methods
• Review the adoption of applicable processes, policies, guidelines, checklists, and templates within projects and support functions (e.g., HR, Training, IT Support, DevOps/Cloud Infrastructure) and provide timely feedback
• Add value in controlling risks, mitigating risks
• Liaise with stakeholders to ensure alignment with adoption of management system in the context of the organization and objective of the organization
• Plan adoption of AI Management System on need basis in applicable entities within the organization
• Support projects and support functions for internal audits and external certifications (e.g. ISO9001:2015, ISO27001:2022), HIPAA compliance, AI Audits etc
• Facilitate methodical Root Cause Analysis for any production issues

Planning, Tracking and Reporting :

• Plan adoption of Management System (e.g. QMS ,ISMS) in the projects and Support Functions.
• Provide summary of adoption of policies, processes etc to management on periodic basis
• Proactively plan call with stakeholders of projects and support functions for highlighting risks, and recommendations to mitigate / control risks
• Provide feedback for improvements in existing process etc .

Maintain Records for Internal Audits and External Certifications :

• Documentation: Maintain evidence of compliance for audits ,inspections and ISO certifications
• Support project teams and support functions in prioritizing actions for addressing Non-Conformances resulted from internal audits, and external audits.
• Provide required support during certifications (e.g. ISO9001, ISO27001), HIPAA compliance check

Required Skills & Qualifications

• B Tech / M Tech/ MCA or Higher
• 10 plus years of experience in Software Quality Assurance for driving adoption of integrated management system (QMS+ISMS) and proactively raising alerts to the respective projects and support function
• Experience in conducting presentations, awareness sessions
• Experience in improving processes, driving adoption of Integrated Management System (QMS, ISMS) and reporting summary to management
• Solid knowledge of SDLC methodologies and ability to evaluate testing and validation activities.
• Strong communication skills to provide oversight and guidance across global teams
• Experience in supporting ISO 27001:2022 certification, ISO9001 certification
• Knowledge and exposure of HIPAA
• Knowledge and exposure of SOC2
• Knowledge and exposure of ISO42001 is added advantage
• Knowledge and exposure of 21 CFR Part 820, and GAMP 5 guidelines for risk-based validation of computerized systems