Software Quality & Compliance Manager (SQA)

Experience

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Qualifications:

Work Timings:

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 adoption of 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 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 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

Skills, Knowledge, and Experience:

• 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 to HIPAA
• Knowledge and exposure to SOC2
• Knowledge and exposure to ISO42001 is an advantage.
• Knowledge and exposure to 21 CFR Part 820, and GAMP 5 guidelines for risk-based validation of computerized systems