{"id":3051394,"url":"https://alion.io/job/sandoz-global-senior-gmp-auditor","title":"Global Senior GMP Auditor","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":81,"open_postings":36,"ghost_share":0,"stale_share":0.972,"repost_share":0,"time_to_fill_p50_days":17,"computed_at":"2026-11-05T05:54:30Z"}},"role":"Finance","role_family":"Finance","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":["Madrid, Spain"],"countries":["ES"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":44000,"max_usd":109000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":13},"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-10-02T00:00:00Z","employer_posted_date":"2026-10-02","last_verified_at":"2026-11-05T20:07:24Z","board_verified":true,"closed_at":null,"days_open":34,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":34},"description":"Job Description Summary\nOur global Quality audit team is hiring!Job Description\nAt Sandoz, our goal is not just to increase access, but to do so in a sustainable and responsible way:\nfinding the right balance between guaranteed quality, reliable supply and appropriate pricing. Our aim is to excel at all three, ensuring we never compromise on quality.\n\nto protect our environment (carbon footprint, natural resources), as well as to champion diversity, equity and inclusion across our company and beyond\n\nAs GMP Senior Auditor you'll lead, support and report independent GMP audits according to the Sandoz Quality System and the current GMP regulations to assess compliance with applicable regulations, standards, and guidance documents. Review and approve corrective action plans in support of the audit observations. The audits performed include internal and external targets of manufacturing sites, development centers, quality systems, contract manufacturers, laboratories, warehouses, country organizations, and suppliers.\nEnsure alignment with strategic direction of the company and assist in driving implementation of the applicable actions. Provide consultation to Sandoz business units through risk based assessments. Act as SME for assigned areas of responsibility.\nYour responsibilities will include:\nSupport the strategic development of an effective global risk-based audit strategy and program. Collect, collate, and incorporate input into the audit strategy and plan.\n\nPlan, lead, conduct, document, and follow-up of GMP audit according to the requirements specified in the respective Sandoz Quality procedures as well as applicable regulations, standards, quality agreements, and guidance documents.\n\nFor this role, auditors will be given more complex and higher-risk audits, such as sterile API, aseptic DP, and combination products. The ability to assess risk of these operations is critical to success.\n\nProvide technical guidance, mentoring, and training on audit activities.\n\nProvide regulatory guidance for timely remediation and recommendations regarding acceptability of the proposed filing.\n\nPrepare audit reports according to Sandoz requirements and timelines.\n\nEnsure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to Sandoz requirements on Management Escalations and other relevant procedures. Ensure adequate definition and recording of mitigation plans when applicable.\n\nAssess the adequacy of responses (CAPA plans) to audit findings in cooperation with the stakeholder QA representative and Auditee.\n\nAct as GMP compliance consultant for GMP trainings, task forces, continuous improvement projects as needed. Assure permanent transfer of best practice identified during the audit into Sandoz QMS system\n\nReview and advise on relevant policies and procedures.\n\nMentor junior GMP staff as required.\n\nMaintain current knowledge of regulations, standards, and guidance documents.\n\nIdentify and report best practices and lessons learned to support development/training of GMP auditors.\n\nWhat you need to bring to the role:\nDegree in Chemistry, Pharmacy, Biology, Engineering or another related science. Advanced degree preferred. Other degrees with relevant experience may be accepted\n\nExcellent oral and written English communication skills. Good knowledge/mother tongue of an additional language (e.g. German, French, Italian, Chinese, or Spanish) is valued.\n\nAt least 10 years broad experience in Pharmaceutical or Medical Device Industry.\n\nThe operational experience should include QA/QC management and manufacturing, or development or other relevant experience e.g. working at a regulatory health authority.\n\n3 years auditing experience preferred, and excellent knowledge of regulatory requirements.\n\nWillingness to travel approximately 60% of the time.\n\nExpertise in at least one of the following areas: DP Manufacturing, Laboratories activities, Medical Devices, API, Excipients, Sterile, Biologics, Microbiology, Computer System Validation, Packaging activities, Quality Systems.\n\nExperience and/or interaction with local Health Authority and sporadically with other Health Authorities.\n\nStrong interpersonal skills, including diplomacy and persuasion, used in obtaining cooperation and consensus with Novartis colleagues, vendors and customers.\n\nSound and practical judgement in the interpretation and application of regulations and standards\n\nAbility to independently manage and objectively evaluate complex compliance issues with minimal supervision\n\nExcellent leadership and facilitation skills\n\nWhat You'll Receive\nSandoz compensation is determined by job level, qualifications, niche skills, experience, and location within company salary ranges. Fully proficient and highly effective employees can expect a starting salary around market median, with those new to the level or with less functional depth at the lower end of the range and those with sustained superior or niche skills towards the higher end of the range. Internal equity and external market data inform our range placement. Annual salary reviews consider performance outcomes, market alignment, and business needs.\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!\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.\nHiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.\n#Sandoz\nSkills Desired\nAuditing, Audit Management, Communication Skills, Compliance Audits, Compliance Risk, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gmp Procedures, Inspection Readiness, Organizational Skills, People Management and Leadership, Qa (Quality Assurance), Regulatory Compliance, Risk Management, Self-Awareness, Technological Expertise","description_format":"text","description_chars":6757,"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":[{"language":"English","level":"Upper-Intermediate (B2)","optional":false}]},"benefits":["Equity"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Pharmaceutical 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