Job Description: Quality Assurance Manager Location: Madhapur, Hyderabad Employment Type: Full-Time Job Summary The Quality Assurance Manager will oversee quality assurance processes for our clinical trial software and AI systems, ensuring compliance with global regulatory requirements, including USFDA (21 CFR Part 11), GDPR, HIPAA, ICH-GCP, ISO 90001 & 27001 and other relevant standards. This role requires deep expertise in Computer System Validation (CSV). With 10+ years of experience, the ideal candidate will lead a QA team, collaborate with cross-functional groups, and drive continuous improvement to deliver reliable, compliant, and innovative solutions. Key Responsibilities of a Quality Assurance Manager Regulatory Compliance Ensure software and AI systems comply with USFDA (21 CFR Part 11, 820), GDPR, HIPAA, ISO 13485, and other global standards. Stay updated on evolving healthcare AI regulations and integrate them into QA practices. Prepare for and support audits by regulatory bodies, clients, and third parties. Computer System Validation (CSV) Lead development and maintenance of CSV protocols (IQ, OQ, PQ) for software and AI systems. Ensure validation documentation aligns with GxP standards and is audit-ready. Collaborate with IT and development teams on system updates and new features. QA Strategy & Leadership Develop and implement QA strategies using risk-based validation approaches. Manage and mentor QA teams, fostering a quality-focused culture. Monitor KPIs for software and AI quality and compliance. Process Improvement Create and maintain SOPs for QA, CSV, and AI validation. Conduct root cause analysis and implement CAPAs. Drive initiatives to improve system performance, security, and reliability. Cross-Functional Collaboration Partner with product, development, and AI teams to integrate quality into the SDLC. Translate client and stakeholder requirements into actionable QA plans. Support implementation and post-deployment activities to ensure satisfaction. Risk Management Conduct risk assessments per ISO 14971 and ICH Q9, addressing AI-specific risks (e.g., model bias). Mitigate risks related to data integrity, security, and compliance. Training & Documentation Provide training on QA, CSV, AI validation, and compliance. Maintain thorough documentation of validation activities, audit trails, and quality records. Qualifications Minimum of 10+ years of experience in quality assurance, with at least 5 years in a managerial role within a clinical trial software, CRO, Pharma, Biotech, or Medtech environment. Extensive experience with Computer System Validation (CSV) in a regulated industry. Proven track record of managing QA for software used in global clinical trials. Education: Bachelor's degree in Life Sciences or a related field. Advanced degree (e.g., Masters) or certifications (e.g., ASQ CQA, ISTQB, Six Sigma) preferred. Technical Skills: In-depth knowledge of USFDA regulations (21 CFR Part 11, Part 820), GDPR, HIPAA, ICH-GCP, and ISO standards (e.g., 13485, 14971), including AI-specific guidelines. Proficiency in CSV methodologies and tools (e.g., GAMP 5 framework). Familiarity with clinical trial software platforms (e.g., EDC, IWRS, eTMF, CTMS) and AI-driven solutions in clinical research. Soft Skills: Strong leadership and team management abilities. Excellent problem-solving, analytical, and decision-making skills. Exceptional communication skills, with the ability to liaise with technical teams, AI specialists, regulators, and clients. Detail-oriented with a proactive approach to quality and compliance. Why Join Us? Impactful Work : Contribute to cutting-edge AI-enabled solutions that accelerate clinical trials and improve global healthcare outcomes. Innovative Culture : Be part of a dynamic team that embraces new ideas, challenges the status quo, and drives innovation. Growth Opportunities : Access professional development opportunities in a rapidly growing company committed to employee success. Work-Life Balance : Enjoy a supportive work environment with flexible work arrangements.

Dear Professionals, We are currently hiring for the position of Senior ServiceNow Developer . This is an excellent opportunity for professionals seeking a completely remote, full-time role with a stable and dynamic team. Position Details: Role: Senior ServiceNow Developer Location: Remote (Work from Anywhere in India) Employment Type: Full-time Shift Timings: 4:00 PM IST to 1:00 AM IST Important Notes: Only immediate joiners or those with a maximum 1-month official notice period will be considered. Candidates must match at least 70% of the job description to apply. Please do not apply if you do not meet the above criteria. Overview We are currently seeking a senior ServiceNow Developer to be the sole and primary developer for an established ServiceNow ITSM instance supporting all internal worldwide company employees. The work location for this position is in India, and it is a full-time remote in India. The workdays are Monday through Friday; the hours are from 4 PM IST to 1 AM IST (Local India Time) which includes a one-hour break. You must be located in India and able to work 100% remote. Responsibilities You will be our primary developer for our ServiceNow ITSM instance. The applications/modules currently deployed include service catalog & self-service portal with integrated chat, mobile, incident, request, knowledge, service workflows, notifications, feature center & agile, custom tables, performance analytics, integration with Microsoft PowerBI, and more. Our upcoming roadmap includes implementing change management and automate additional laborious processes within the company. You will be responsible for the entire ServiceNow environment which includes day-to-day maintenance and patching, resolution of service interruptions, integrations, and enhancements. This position will be the only ServiceNow developer at this time. You will make all architectural decisions on how to develop, enhance and implement change. This position will collaborate with the ServiceNow business analysis team located in the US on Eastern time. External consultants may be brought in to assist you on an as needed basis during significant enhancements. Qualifications 6+ years of experience architecting, designing, developing, implementing & maintaining ServiceNow ITSM in an enterprise environment 6+ years of experience with the core ServiceNow applications (Service catalog, chat, incident, request, problem, knowledge, change, reporting analytics, etc.) 6+ years of experience with ServiceNow data, reporting, dashboards, and integrations with PowerBi or similar 6+ years of experience with scripting & automation within ServiceNow utilizing JavaScript, Glide API, and Flow Designer 6+ years of experience in JavaScript, HTML, CSS, and Glide scripting + years of experience with workflows, business rules, client scripts, and UI policies 8+ years of in-depth experience utilizing workflows and building custom applications to automate business processes 8+ years of in-depth experience with integrations using Azure SSO, SAML, REST, SOAP, MID Server, ServiceNow Integration Hub and API-based connections 8+ years of in-depth experience architecting ServiceNow Experience with agile methodologies is a must Associates degree minimum Experience with ServiceNow HR, ITOM, AIOps is a plus (but not required) ServiceNow certification is a plus (but not required) ITIL certification is a plus (but not required)