Software Quality & Compliance Manager (SQA)

Remote Full-time
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 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


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