{"id":2488856,"url":"https://alion.io/job/biogen-principal-auditor-quality-audits","title":"Principal Auditor, Quality Audits","company":{"id":449685,"name":"Biogen","domain":"biogen.com","url":"https://alion.io/company/biogen-2","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":75,"open_postings":19,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":27,"computed_at":"2026-10-24T06:02:35Z"}},"role":"Finance","role_family":"Finance","seniority":"lead","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Baar, Switzerland"],"countries":["CH"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":null,"experience_years_min":13,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false}],"status":"live","first_seen_at":"2026-10-14T01:24:27Z","employer_posted_date":"2026-10-14","last_verified_at":"2026-10-22T06:12:39Z","board_verified":false,"closed_at":null,"days_open":10,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":10},"description":"About This Role:\nAs part of the Corporate Quality team, you will play a key role in Quality Audits, with a focus on internal and external audits, supplier and partner oversight, and inspection readiness. Based in Baar, Switzerland, the role has a broad scope across Europe and Rest of World regions.\nDepending on experience and level, you will independently plan, lead, and execute audits across GMP/GDP, ISO 13485 and global GxP regulatory frameworks, with a strong focus on regulatory expectations including EMA and country-specific health authority requirements.\nAt Principal level, you will take the lead on complex, high-risk audits, provide senior technical expertise, engage with site leadership and senior quality stakeholders, and coach other auditors. At Senior Associate III level, you will independently lead audits and contribute to the execution of the regional audit program, building further expertise in complex and multi-country auditing. Across both levels, you will contribute to strong quality governance, inspection readiness, effective remediation, and the continued development of auditing capabilities within the team.\nWe are primarily recruiting for a Principal Auditor, Quality Audits. However, we recognize that strong candidates may bring different levels of experience and expertise. Candidates who demonstrate strong auditing capabilities but do not fully meet the Principal-level requirements may also be considered for a Senior Associate III, Quality Audits opportunity within the team, with level and responsibilities determined based on experience and qualifications.\nWhat You’ll Do:\nIndependently plan, lead, and execute complex, high-risk internal GMP/GDP and ISO 13485 audits across Europe and Rest of World.\nLead and execute for-cause external audits of critical suppliers, contract manufacturers, and service providers.\nApply advanced risk-based auditing methodologies incorporating regional regulatory nuances.\nPrepare inspection-ready audit reports.\nReview, challenge, and approve CAPA responses for complex findings, and monitor remediation progress.\nServe as a senior technical resource and coach auditors during execution of complex audits.\nSupport the Associate Director in executing the regional audit program, including audit schedule coordination.\nProvide expert input for regulatory interactions and inspection readiness.\nMentor auditors and contribute to strengthening overall audit capability.\nCommunicate critical findings and compliance gaps with senior-level context.\nInfluence remediation strategies and monitor resolution of significant quality issues.\nWho You Are:\nYou are a highly skilled auditor with a passion for quality assurance and regulatory compliance. You possess the ability to think critically and navigate complex regulatory environments with ease. Your dedication to excellence drives you to execute audits with precision and integrity. You are a natural leader who thrives in collaborative settings, easily communicating complex audit findings and influencing remediation strategies. Your attention to detail and commitment to continuous improvement make you an invaluable resource to your team and the organization.\nRequired Skills for Principal Auditor, Quality Audits\nBachelor of Science in Life Science, Engineering, or related technical discipline (advanced degree preferred).\nMinimum of 13+ years experience in a regulated pharmaceutical, biotechnology, or medical device environment.\nMinimum of 5+ years progressive auditing experience, including leadership of complex, multi-country audits.\nDemonstrated expertise in EMA expectations, ISO 13485, and global GxP frameworks.\nFluent in English.\nPreferred Skills - Principal Auditor, Quality Audits\nAdvanced terminal degree (MD, PhD, PharmD).\nExperience in coaching and mentoring auditors.\nRequired Skills for Senior Associate III, Quality Audits\nBachelor of Science in Life Science, Engineering, or related technical discipline.\nMinimum of 10+ years of experience in a regulated pharmaceutical, biotechnology, or medical device environment.\nMinimum of 4+ years of auditing experience, including independent Lead Auditor responsibilities.\nDemonstrated experience with ISO 13485 and global GxP regulatory frameworks (FDA, EMA).\nProficiency in English.\nPreferred Skills - Senior Associate III, Quality Audits\nAdvanced terminal degree (MD, PhD, PharmD).\nFluency in additional languages.\nExperience with supplier qualification processes.\n\nJob Level: ManagementWhy Biogen?\nWe are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.\nAt Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.\nAll qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.","description_format":"text","description_chars":5872,"description_truncated":false,"requirements":{"experience_years_min":13,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":[],"hiring_locations":[{"name":"Switzerland","iso":"CH","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Prescription Drugs","Neurology & CNS Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-14T01:24:27Z"}],"visa":[],"liveness":{"score":57,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":0.9,"age_days":10,"expected_fill_days":27,"reasons":["conf:47","stale_co","velocity","win:mid","comp:brand"],"computed_at":"2026-10-24T06:02:35Z"},"pay":null,"html_url":"https://alion.io/job/biogen-principal-auditor-quality-audits","json_url":"https://alion.io/job/biogen-principal-auditor-quality-audits.json","meta":{"generated_at":"2026-10-24T20:39:21Z","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":30118,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-25T00:00:00Z"}},"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":449685},"rest":"https://alion.io/mcp/rest/get_company?id=449685"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fbiogen-principal-auditor-quality-audits"},{"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%2Fbiogen-principal-auditor-quality-audits"},{"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%2Fbiogen-principal-auditor-quality-audits"},{"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/biogen-principal-auditor-quality-audits\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fbiogen-principal-auditor-quality-audits"}]}