{"id":3233253,"url":"https://alion.io/job/sandoz-senior-development-quality-manager-bdl","title":"Senior Development Quality Manager - BD&L","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":{"grade":"B","score":80,"open_postings":35,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":11,"computed_at":"2026-10-26T05:57:25Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"lead","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":48000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":14},"experience_years_min":15,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GCP","optional":false},{"name":"GLP","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-10-22T00:00:00Z","employer_posted_date":"2026-10-22","last_verified_at":"2026-10-27T04:37:07Z","board_verified":true,"closed_at":null,"days_open":5,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":5},"description":"Job Description Summary\nSandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape!Provide quality assurance and compliance oversight to development and research functions. Drive the oversight of quality management systems and initiatives within the global, regional, and country organization, ensuring compliance with applicable health authority regulatory requirements (e.g., GCP, GLP, GMP, PV, IP) and Sandoz procedures and quality standards. Role model good quality behaviors while promoting a culture of quality (e.g., right first time, etc.) to positively impact the non-quality stakeholders (e.g., , SGD/Development). Develop, drive and/or support Quality plan initiatives in order to achieve organizational strategy, mission and vision.\nJob Description\nYour Key Responsibilities:\nYour responsibilities include, but not limited to:\nConduct comprehensive due diligence for regional & global early-stage Business Development & Licensing (BD&L) opportunities, assessing quality, compliance, risks, and probability of success.\nAssess GMP/GDP compliance status, quality systems, and inspection history of potential partners and GMP sites\nIdentify critical risks, compliance gaps, and “showstoppers” impacting deal feasibility and probability of success (POS). Provide quality input to BD&L decision-making and governance boards\nLead the negotiation and implementation of Quality Agreements (QAA) for early development collaborations, ensuring alignment with regulatory expectations and company standards.\nRepresent Quality as a key stakeholder in cross-functional internal and external project teams, driving decision-making and ensuring quality considerations are embedded throughout development.\nEnsure alignment between Good Development Practices (GDP) and GMP requirements. Evaluate deviations, OOS (Out of Specification), and OOT (Out of Trend) investigations to ensure robust root cause analysis and implementation of effective CAPA measures.\nReview and approve GMP-relevant change controls impacting regulatory dossiers, ensuring compliance and data integrity. Assess quality aspects of submission-relevant data (e.g., CMC documentation, development reports) including:Analytical methods and method validation\nMaster Batch Records (MBRs)\nStability data\nProduct Development Reports (PDRs)\nSpecifications and justification of specifications, ensuring scientific rigor, consistency, and adherence to compendial and quality standards.\n\nSupport pre-approval inspection (PAI) readiness at third-party manufacturing sites and contribute to successful regulatory inspections and dossier approvals.\nEscalate project quality risks and communicate status updates to senior leadership, enabling informed strategic decisions.\nBuild and maintain strong working relationships with quality teams at third-party organizations to foster collaboration and facilitate smooth transition from development to commercial operations. Act as trusted advisor to BD&L and partner organizations on quality topics. Facilitate alignment across cultures, organizations, and quality systems\nWhat you’ll bring to the role:\nEssential Requirements:\nIndustry/ Business Exposure\n15+ years of relevant experience\nCritical Negotiations\nFunctional Breadth\nOperations Management and Execution\nCollaborating across boundaries\nProject Management\nPeople Leadership\nSkills:\nAgility\nAudit Management\nAuditing\nBusiness Partnering\nContinuous Learning\nDrug Development\nHealth Authorities\nInfluencing Skills\nLeadership\nOrganizational Savvy\nPeople Management\nQuality Assurance (QA)\nQuality Management Systems (QMS)\nRisk Management\nRoot Cause Analysis (RCA)\nSelf-Awareness\nStakeholder Management\nTechnological Expertise\nVendor Management\nWhy Sandoz?\nGeneric and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!\nWith investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients 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, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!\nJoin us!\nSkills Desired\nAgility, Auditing, Audit Management, Business Partnering, Continued Learning, Drug Development, Employee Performance Evaluations, Health Authorities, Influencing Skills, ISO 9001, Leadership, Organizational Savvy, People Management, Qa (Quality Assurance), Quality Management, Quality Management Systems (QMS), Risk Management, Root Cause Analysis (RCA), Self-Awareness, Stakeholder Management, Technological Expertise, Vendor Management","description_format":"text","description_chars":5257,"description_truncated":false,"requirements":{"experience_years_min":15,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":["Continuous learning"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Pharmaceutical Distribution"],"lifecycle":[{"event":"open","at":"2026-10-25T09:26:40Z"}],"visa":[],"liveness":{"score":57,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":0.9,"age_days":4,"expected_fill_days":11,"reasons":["conf:5","stale_co","velocity","win:mid","comp:brand"],"computed_at":"2026-10-26T05:57:25Z"},"pay":null,"html_url":"https://alion.io/job/sandoz-senior-development-quality-manager-bdl","json_url":"https://alion.io/job/sandoz-senior-development-quality-manager-bdl.json","meta":{"generated_at":"2026-10-27T04:57:39Z","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":4750,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-28T00:00:00Z"}},"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-senior-development-quality-manager-bdl"},{"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-senior-development-quality-manager-bdl"},{"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-senior-development-quality-manager-bdl"},{"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-senior-development-quality-manager-bdl\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fsandoz-senior-development-quality-manager-bdl"}]}