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