{"id":3318708,"url":"https://alion.io/job/roche-it-quality-specialist-pharma-rd","title":"IT Quality Specialist - Pharma R&D","company":{"id":13531,"name":"Roche","domain":"roche.com","url":"https://alion.io/company/roche","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":85,"open_postings":191,"ghost_share":0.037,"stale_share":0.654,"repost_share":0.105,"time_to_fill_p50_days":20,"computed_at":"2026-11-02T06:13:15Z"}},"role":"Support","role_family":"Support","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Hyderabad, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":13500,"max_usd":31000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":8},"experience_years_min":7,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"Agile","optional":false},{"name":"AI Agents","optional":false},{"name":"GDPR","optional":false},{"name":"HIPAA","optional":false},{"name":"ISO 13485","optional":false},{"name":"Waterfall","optional":false}],"status":"live","first_seen_at":"2026-10-27T06:39:48Z","employer_posted_date":"2026-10-27","last_verified_at":"2026-11-02T23:50:50Z","board_verified":true,"closed_at":null,"days_open":6,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":6},"description":"At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.\nThe Position\nThe IT Quality Specialist independently manages the end-to-end quality and analysis tasks across various capabilities and contributes to solving moderately complex business problems. You will lead the analysis of stakeholders needs, drive root cause analysis, and ensure comprehensive requirements traceability across large-scale initiatives. Acting as a trusted advisor, you will champion accountability, mentor junior team members, and drive process improvements that align delivered solutions with overarching business goals.\nKey Responsibilities\nCollaborate with cross-functional teams, including Product Managers, Architects, Engineers, and UX Designers, to define scope, solutions, constraints, and project risks.\n\nManage compliance documentation processes and systems, characterizing business solutions for compliance with internal and external regulations.\n\nBe accountable for the creation and maintenance of:\nSystem Risk Assessments and Data Classification Reports.\n\nUser Requirements and Functional/Technical Specifications.\n\nValidation Plans, Reports, and Registries.\n\nRequirements Traceability Matrices, Test Plans, and Test Reports.\n\nData/Process flow diagrams and training documentation.\n\nConfigure system settings and provide consultation to customers regarding solution enhancements and new implementations.\n\nFacilitate UAT planning and execution.\n\nServe as a trusted partner for Global Privacy, IT Security, and Business Quality teams, maintaining expert-level knowledge of governance standards (e.g., GDPR, CCPA, HIPAA, 21 CFR Part 11, ISO 13485).\n\nDrive the resolution of business or systems issues throughout the project lifecycle.\n\nEnhance the creation and maintenance of compliance documentation (e.g., System Risk Assessments, Validation Plans, Requirements Traceability Matrices) by leveraging AI-driven automation to reduce manual effort while maintaining compliance rigor.\n\nImplement AI-assisted quality control tools to automate data validation, anomaly detection, and cross-platform consistency checks, ensuring sustained data integrity and adherence to GxP/CSV standards at scale.\n\nUtilize AI-powered analytical tools to monitor platform performance, proactively identify process bottlenecks, and generate audit-ready compliance metrics.\n\nGuide the strategic deployment of AI agents within the IT Quality landscape, ensuring that AI-assisted workflows remain compliant by design and effectively support business requirements.\n\nExperience Profile\n7-10 years of related experience in an IT business systems analyst or IT quality assurance role.\n\nStrong domain knowledge of the pharmaceutical/biotech industry, manufacturing/quality assurance processes, and computer systems validation (CSV).\n\nProven understanding of application development methodologies (Agile and Waterfall), including functional requirements, process modeling, and large-scale system implementations.\n\nBA/BS degree in life science, informatics, business, or equivalent (MA/MS or post-graduate coursework is a plus).\n\nExcellent written and verbal communication, presentation, and facilitation skills.\n\nDemonstrated ability to build relationships, focus on the customer, and solve complex problems in fast-paced environments.\n\nStrong capability to independently apply tools, principles, concepts, and techniques related to requirements, data, usability, and process analysis.\n\nAbility to champion accountability by example, drive process improvement initiatives, and mentor junior team members.\n\nShift: CET time zone\n#Hyderabad2026\nWho we are\nA healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.\nLet’s build a healthier future, together.\nRoche is an Equal Opportunity Employer.","description_format":"text","description_chars":4627,"description_truncated":false,"requirements":{"experience_years_min":7,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Diagnostic Tests & IVD","Biologics & Biosimilars","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-27T06:39:48Z"}],"visa":[],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":5,"expected_fill_days":20,"reasons":["conf:9","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-11-02T06:13:15Z"},"pay":null,"html_url":"https://alion.io/job/roche-it-quality-specialist-pharma-rd","json_url":"https://alion.io/job/roche-it-quality-specialist-pharma-rd.json","meta":{"generated_at":"2026-11-03T01:04:42Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":1156,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-04T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":13531},"rest":"https://alion.io/mcp/rest/get_company?id=13531"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Froche-it-quality-specialist-pharma-rd"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Froche-it-quality-specialist-pharma-rd"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Froche-it-quality-specialist-pharma-rd"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/roche-it-quality-specialist-pharma-rd\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Froche-it-quality-specialist-pharma-rd"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3318708}},{"tool":"search_jobs","arguments":{"company":"roche.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3318708},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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