{"id":2355519,"url":"https://alion.io/job/novartis-manager-rd-quality","title":"Manager, R&D Quality","company":{"id":5824,"name":"Novartis","domain":"novartis.com","url":"https://alion.io/company/novartis","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":86,"open_postings":64,"ghost_share":0,"stale_share":0.547,"repost_share":0.031,"time_to_fill_p50_days":35,"computed_at":"2026-10-14T06:34:16Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":null,"employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Hyderabad, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-12T14:42:42Z","employer_posted_date":"2026-10-12","last_verified_at":"2026-10-14T09:13:02Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"Job Description Summary\n#LI-OnsiteLocation: HYD, India\nThis role is based in Hyderabad, India. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible for you.\nThe Manager, R&D Quality provides quality assurance expertise and oversight for research and development activities, with a particular focus on oligonucleotide and xRNA analytics. The role partners with cross-functional teams to ensure compliance with applicable GxP regulations, regulatory requirements, Novartis procedures and quality standards.\nJob Description\nMajor Accountabilities:\nSupport maintenance of the regulatory -required files for health authority inspections and assist with health authority inspection management\nSupport generation of Quality Plans (and review other plans for quality/safety aspects) for clinical programs\nSupport review of Oligonucleotide Analytics, including analytical methods, stability, control strategies, impurities, and quality risk assessment.\nSupport cross functional CMC, regulatory, and lifecycle initiatives for oligonucleotide drug substances and drug products.\nSupport initiatives to maintain or improve quality performance and compliance of operational activities including risk management, health authority reporting, IT systems\nSupport initiatives focused on quality, process and compliance improvement, including identification of opportunities and develop strategies aimed at improving quality while ensuring compliance with regulatory requirements\nEnsure information gained during quality and compliance initiatives, as well as audit and assessment results, are evaluated to identify any regulatory, compliance and QA training needs\nAid in the identification of quality issues and assist with root cause investigations and support the development of corrective and preventative action plans (CAPA), including monitoring status to Ensure issues are addressed, completed and documented.\nProvide assistance in the remediation of deviations, Ensure follow up and monitoring of associated corrective and preventive actions.\nManage and Support quality aspects of projects and activities, including those related to third parties, analytical instruments, manufacturing equipment, quality plans, training, IT validations, etc.\nReview and approve quality deliverables to ensure compliance (including procedures, records, third party work, contractors, clinical trial material, components, gap assessments)\nReporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt\nDistribution of marketing samples (where applicable)\n Minimum Requirements:\nWorking knowledge of oligonucleotide modalities and therapeutics (e.g., siRNA, ASO, mRNA, and conjugated oligonucleotides).\nUnderstanding of oligonucleotide manufacturing, analytical characterization, stability, and control strategy concepts.\nFamiliarity with oligonucleotide-specific CMC development, lifecycle management, and regulatory considerations.\nAwareness of critical quality attributes (CQAs), impurity profiles, degradation pathways, and product quality risks associated with oligonucleotide therapeutics.\nUnderstanding of analytical method lifecycle concepts, including method development, validation, transfer, and ongoing performance monitoring.\nFamiliarity with oligonucleotide drug substance and drug product development considerations, including formulation and comparability strategies.\nAbility to assess quality risks and provide quality oversight for oligonucleotide development programs.\nAbility to interpret technical, analytical, and quality data to support risk-based decision making.\nEffective collaboration with technical SMEs across analytical, process, regulatory, pharmaceutical development, manufacturing, and quality functions.\nAbility to support cross-functional discussions on emerging xRNA modalities, platform approaches, and evolving regulatory expectations.\nBenefits & Rewards\nAt Novartis, we’re committed to reimagining medicine together - and rewarding the people who make it happen.\nExpected Annual Base Salary Range for role:2,436,000.00 - 4,524,000.00 INR\nThe base salary offered is determined based on gender-neutral objectives, such as relevant skills, competencies and experience in accordance with the Novartis pay setting policy and upon joining Novartis will be reviewed periodically.\nIn addition to your base salary, you may be eligible for a performance-based bonus depending on certain performance parameters.\nThe rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits in kind to help you thrive personally and professionally, such as insurance plans, retirement plans, wellbeing resources and global recognition programs. In addition, we provide flexible and hybrid working options, where possible, and minimum 14 weeks paid parental leave.\nRead our brochure to learn more about our global total rewards offering:\nhttps://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf\nNote: Benefits and compensation may vary by country and are subject to local legal requirements, including provisions of collective bargaining agreements where applicable. A full overview of your compensation package, including any relevant collective bargaining agreement details applicable to your role based on your employment location and Novartis employer entity, will be communicated separately to you during the application process.\nCommitment to Diversity and Inclusion / EEO paragraph\nNovartis is committed to building an outstanding, inclusive work environment and diverse teams’ representative of the patients and communities we serve.\nAccessibility and accommodation\nNovartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to  and let us know the nature of your request and your contact information. Please include the job requisition number in your message\nSkills Desired\nCollaboration, Communication, Corrective and Preventive Action (CAPA), Data Integrity, Good Manufacturing Practices (GMP), Inspection Management System, Operational Excellence, Performance Auditing, Problem Solving, Quality Assurance (QA), Quality Compliance, Quality Management, Quality Management Systems (QMS), Regulatory Compliance, Stakeholder Management, Standard Operating Procedure (SOP)","description_format":"text","description_chars":6665,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":["Hybrid work","Parental leave","Retirement plans"],"hiring_locations":[{"name":"India","iso":"IN","kind":"country"}],"hiring_excludes":[],"relocation_offered":true,"industries":["Oncology Therapeutics","Neurology & CNS Therapeutics","Immunology & Inflammation Therapeutics","Cardiometabolic Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-12T14:42:42Z"}],"visa":[],"liveness":{"score":60,"band":"ok","label":"Likely open","p_open":1,"p_active":0.602,"p_room":1,"age_days":1,"expected_fill_days":35,"reasons":["conf:3","stale_co","win:early","comp:brand"],"computed_at":"2026-10-14T06:34:16Z"},"pay":null,"html_url":"https://alion.io/job/novartis-manager-rd-quality","json_url":"https://alion.io/job/novartis-manager-rd-quality.json","meta":{"generated_at":"2026-10-14T13:35:25Z","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":16686,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-15T00:00:00Z"}},"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":5824},"rest":"https://alion.io/mcp/rest/get_company?id=5824"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fnovartis-manager-rd-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%2Fnovartis-manager-rd-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%2Fnovartis-manager-rd-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/novartis-manager-rd-quality\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fnovartis-manager-rd-quality"}]}