{"id":3229166,"url":"https://alion.io/job/sandoz-manager-gqs-csv-digital-quality","title":"Manager GQS CSV & Digital Quality","company":{"id":453557,"name":"Sandoz","domain":"sandoz.com","url":"https://alion.io/company/sandoz-3","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"Operations","role_family":"Operations","seniority":"staff","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":19000,"max_usd":42000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":720},"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 11","optional":false},{"name":"CAPA","optional":false},{"name":"GMP","optional":false},{"name":"LIMS","optional":false},{"name":"Veeva","optional":false}],"status":"live","first_seen_at":"2026-10-22T00:00:00Z","employer_posted_date":"2026-10-22","last_verified_at":"2026-10-26T00:08:37Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"Job Description Summary\n• Serve as a senior subject matter expert for Computerized System Validation (CSV), Digital Quality, Data Integrity, AI Governance and digital compliance across the Sandoz organization.Provide quality and compliance oversight for GxP computerized systems, digital platforms, data solutions, AI capabilities and automation technologies throughout their lifecycle.\nSupport the implementation of Compliance by Design, Quality by Design, digital transformation and process simplification initiatives while ensuring alignment with applicable regulatory requirements and industry best practices.\n• Partner with Quality, Digital and IT stakeholders to enable compliant, efficient and sustainable digital solutions across Development, Manufacturing, Quality, Supply Chain and Commercial functions.\nJob Description\nPosition Purpose:\nServe as a senior subject matter expert for Computerized System Validation (CSV), Digital Quality, Data Integrity, AI Governance and digital compliance across the Sandoz organization. Provide quality and compliance oversight for GxP computerized systems, digital platforms, data solutions, AI capabilities and automation technologies throughout their lifecycle. Support the implementation of Compliance by Design, Quality by Design, digital transformation and process simplification initiatives while ensuring alignment with applicable regulatory requirements and industry best practices. Partner with Quality, Digital and IT stakeholders to enable compliant, efficient and sustainable digital solutions across Development, Manufacturing, Quality, Supply Chain and Commercial functions.\nYour Key Responsibilities:\nYour responsibilities include, but not limited to:\nCSV & Digital Quality Oversight\nProvide quality oversight and guidance for GxP computerized systems, digital platforms, data solutions, AI capabilities and automation technologies.\nSupport implementation and maintenance of CSV and Digital Quality frameworks, standards and procedures.\nEnsure validation and compliance activities are conducted in accordance with applicable regulatory requirements and internal standards.\nContribute to regulatory inspections, audits and remediation activities related to computerized systems and digital solutions.\n margin-top:0cm;\"> margin-top:0cm;\">undefined\nCompliance & Risk Management\nSupport compliance with global GxP requirements, Annex 11, 21 CFR Part 11, Data Integrity principles, GAMP5, CSA and applicable AI regulations.\nPerform risk assessments and support risk-based validation approaches for computerized systems and digital solutions.\nReview validation documentation and ensure compliance throughout the system lifecycle.\nIdentify potential compliance gaps and support implementation of corrective and preventive actions.\n margin-top:0cm;\"> margin-top:0cm;\">undefined\nEnd-to-End Digital Quality Support\nMaintain oversight of assigned digital solutions, computerized systems, interfaces and supporting processes.\nSupport lifecycle activities including requirements, validation, implementation, operation, monitoring, change management and retirement.\nDrive standardization and harmonization of validation practices and digital quality processes.\nIdentify opportunities to improve compliance, efficiency and effectiveness through digitalization, automation and modern validation approaches.\nundefined\nAI, Data & Automation Quality Assurance\nProvide quality oversight for AI, Generative AI, advanced analytics and intelligent automation solutions used in GxP-relevant processes.\nSupport qualification, validation, monitoring and lifecycle management activities for AI-enabled solutions.\nAssess compliance risks associated with digital innovations and recommend appropriate controls.\nSupport implementation of governance requirements for explainability, traceability and data integrity.\n margin-top:0cm;\"> margin-top:0cm;\">undefined\nBusiness Partnership & Project Support\nPartner with Quality, Digital, IT and Business functions to ensure quality and compliance requirements are appropriately incorporated into digital initiatives.\nParticipate in project teams as Digital Quality subject matter expert.\nSupport deployment of new digital solutions and system enhancements.\nProvide guidance and training on CSV, Digital Quality and Data Integrity requirements.\n margin-top:0cm;\"> margin-top:0cm;\">undefined\nContinuous Improvement & Knowledge Management\nMonitor regulatory developments, industry trends and emerging technologies relevant to CSV and Digital Quality.\nSupport development and maintenance of standards, procedures, templates and best practices.\nContribute to inspection readiness, continuous improvement initiatives and knowledge-sharing communities.\nPromote risk-based and pragmatic compliance approaches aligned with business objectives.\nKey performance indicators:\nCompliance & Inspection Readiness\nSuccessful support of inspections, audits and compliance assessments.\nTimely closure of digital quality observations and CAPAs.\nInspection readiness of assigned systems and digital solutions.\nDigital Quality Excellence\nAdoption of risk-based validation and CSA approaches.\nTimely completion of validation deliverables and quality reviews.\nImproved standardization and efficiency of validation activities.\nDigital Transformation Support\nEffective support of digital initiatives and system implementations.\nIntegration of Compliance by Design principles into project delivery.\nPositive stakeholder feedback and business partnership.\nAI & Digital Governance\nTimely completion of AI and digital compliance assessments.\nEffective support of AI governance requirements.\nSustainable implementation of compliant digital innovations.\nWhat you’ll bring to the role:\nEssential Requirements:\n10-15 years of overall experience with significant experience in CSV, Digital Quality, IT Quality or GxP Compliance within the pharmaceutical industry.\nStrong understanding of global regulations and Health Authority expectations governing computerized systems validation, lifecycle management, Data Integrity and 21 CFR Part 11 requirements.\nExperience supporting development, implementation and lifecycle management of computerized systems in regulated environments.\nExperience with Cloud, SaaS, digital and AI-enabled platforms used in GxP environments.\nExperience with validation and quality oversight of systems such as SAP, ERP, Veeva, MES, LIMS, CDS and related platforms.\nUnderstanding of AI, Generative AI and advanced analytics deployment within regulated environments.\nExperience working in cross-functional and global project teams.\nExperience supporting supplier qualification and computerized system compliance activities.\nStrong communication, influencing and stakeholder management skills.\nProven ability to work independently, manage multiple priorities and deliver results in a complex matrix environment\nWhy Sandoz?\nSandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more, so that everyone can achieve the basic human right of access to good healthcare.\nWith investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably.\nOur momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported!\nJoin us, help us make healthcare fairer and faster.\nCommitment to Diversity & Inclusion:\nWe are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.\nSkills Desired\nAgility, Business Acumen, Business Partnering, Collaboration / Teamwork, Communication Skills, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gmp Procedures, Goal-Oriented, Health Authorities, Leadership, Logical Thinking, Problem Solving Skill, Problem Solving Skills, Qa (Quality Assurance), Self-Awareness, Smart Risk Taking, Sop (Standard Operating Procedure) , Technological Expertise","description_format":"text","description_chars":8481,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Pharmaceutical Distribution"],"lifecycle":[{"event":"open","at":"2026-10-25T07:32:09Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":4,"expected_fill_days":36,"reasons":["conf:1","win:early","comp:brand"],"computed_at":"2026-10-26T02:00:19Z"},"pay":null,"html_url":"https://alion.io/job/sandoz-manager-gqs-csv-digital-quality","json_url":"https://alion.io/job/sandoz-manager-gqs-csv-digital-quality.json","meta":{"generated_at":"2026-10-26T02:00:19Z","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":2569,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-27T00:00:00Z"}},"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":453557},"rest":"https://alion.io/mcp/rest/get_company?id=453557"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fsandoz-manager-gqs-csv-digital-quality"},{"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%2Fsandoz-manager-gqs-csv-digital-quality"},{"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%2Fsandoz-manager-gqs-csv-digital-quality"},{"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/sandoz-manager-gqs-csv-digital-quality\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fsandoz-manager-gqs-csv-digital-quality"}]}