{"id":2460480,"url":"https://alion.io/job/sobi-external-quality-operations-manager-2","title":"External Quality Operations Manager","company":{"id":4965,"name":"Sobi","domain":"sobi.com","url":"https://alion.io/company/sobi","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SmartRecruiters","truth_index":null},"role":"Management","role_family":"Management","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Stockholm, Sweden"],"countries":["SE"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":64000,"max_usd":144000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":5330},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-10-13T07:18:50Z","employer_posted_date":"2026-10-13","last_verified_at":"2026-10-14T05:28:34Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application! \nAt Sobi, the work we do every day redefines the standards of care and transform the lives of people living with rare diseases.\nAs a diverse team of entrepreneurial people, we are passionate about our growth journey towards becoming a global leader, making a difference for rare disease patients, moving quickly and always challenging the status quo.\nWe are committed to an inclusive, sustainable and flexible workplace that fosters growth and development.\n As External Quality Operation Manager (EQOM), you will play a central role in ensuring strong quality oversight of external manufacturing partners and supporting the reliable supply of high-quality medicines. Acting as the main quality interface with Contract Manufacturing Organizations (CMOs), you will collaborate closely with internal stakeholders across Sobi in a fast-moving, global environment.\nThis is a hands-on role combining operational responsibility with continuous improvement. You will help ensure compliance, strengthen partnerships and contribute to developing efficient, future-ready ways of working.\nThis position is a Hybrid role, based in our Global Hub in Basel Switzerland or Headquarter in Stockholm, Sweden reporting directly to the Associate Director, External Quality Operations.\nKey Responsibilities\nPerform as EQOM to act as Single point of contact for all quality related activities at the Contract Manufacturing Organization (CMO) \nEnsure that all aspects of handling, manufacturing, distribution of products are in compliance with Sobi Quality system, the effective Quality Technical Agreement, that they meet relevant CGMP regulatory requirement. \nSupport the products release by acting as QP Delegate according to delegation documents, when necessary \nSupport the External Service Provider (CMO) Qualification \nEnsure Quality Technical Agreement (QTA) be established appropriately and ensure valid QTA clearly defines roles & responsibilities between Sobi and the External Supplier \nEnsure implementation and maintaining Quality Risk Assessment and KPIs on Quality External activities. Guide defining & monitoring remediation plans to ensure that issues are suitably addressed. Drive or support improvement opportunities for processes and product Quality performance \nEnsure CMO provides product reviews or data (APQR/PQRs, stability reports) as specified in the QTA. Assess the performance of the product and the process as per Sobi requirement \nManage/approve quality issues (deviations, CAPA and complaints) as per QTA and Sobi requirement \nEnsure that Change requests either from CMO or from Sobi are managed according to the QTA and Sobi requirements \nSupport that Quality Audits of the CMO is performed according to Sobi requirement and the QTA \nLead to define strategy of implementation and monitoring of key Quality transformation initiatives and align with all process stakeholders outside of Quality organization \nLead or act as Quality representative in project related to CMO eg Tech Transfer, Launch \nAssess and ensure CMO readiness for Health Authorities (HAs) inspection \nSupport HA inspections/audits of Sobi \nResponsible to inform the line manager and cross functional teams of all critical & major issues and escalate any issues as per Sobi escalation policy \nEnsure a good collaboration is maintained within the Global Quality Operations and cross-functionally \n You thrive in a dynamic, international environment where priorities evolve and collaboration is essential. You are proactive, flexible and comfortable taking ownership, with the ability to balance operational detail and a broader quality perspective.\nYou enjoy building strong relationships, influencing external partners and working cross-functionally to find practical solutions. Open to change and new ways of working, you bring energy, structure and a continuous-improvement mindset - and you are motivated by the opportunity to make a real difference for patients.\nKey Qualifications\nRequired:\nHigh level education (university degree or similar) within relevant area such as pharmaceutical, biotech or life science \nMore than 5 years of experience within pharmaceutical, biotech product. Experience in QA operation, production or other relevant area (GMP, GDP) \nMore than 1 years of managing external quality oversight of CMOs \nCurriculum is requested for evaluating the batch release qualification requirement \nFluently spoken and written English \nDesired:\nMore than 2 years of working in global operation environment with English as a main language \nProven experience of leading Quality KPI assessment and improvement at CMOs \nProven track record with FDA; EMEA or other Health Authorities \nStrong understanding of risk assessment and risk management fundamentals / tools \nHere at Sobi we live by our core values: Care, Ambition, Urgency, Ownership and Partnership!\n How to apply\nWe have an ongoing selection process in this recruitment and ask you to send your application as soon as possible. Click apply and include your resume in English\nWhy Join Us?\nWe are differentiating ourselves through the passion of our people, the innovative products we bring to life, and the responsible business we operate.\nTo ensure that more patients benefit from our therapies now and in the future, and to align with the company’s ambitions for growth, we have five core values: Care, Ambition, Urgency, Ownership and Partnership.\nOur mission and purpose get us excited to come to work every day, but there are a few more reasons to join our team:\nOpportunities for professional growth \nCompetitive compensation for your work \nDiversity and Inclusion \nA flexible workplace that supports work-life balance \nAbout Sobi\nSobi is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases.\nWe are dedicated to capturing the scientific opportunities of our time. With our early roots in Sweden, we started as pioneers in Haemophilia. Today we are an innovate leader within rare diseases with a global reach.\nWe are bringing brilliant ideas to life in rare disease areas with high unmet patient needs. \nWe are experts on identifying breakthrough innovations, unlocking new therapies and levelling up global access to new treatments. \nOur global operational network and passionate team serve as the foundation for our success. \nSobi has approximately 2,000 employees across Europe, North America, the Middle East, Asia and Australia. In 2025, revenue amounted to SEK 28 billion. Sobi’s share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.","description_format":"text","description_chars":6889,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":["Flexible schedule"],"hiring_locations":[{"name":"Sweden","iso":"SE","kind":"country"},{"name":"Switzerland","iso":"CH","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Biologics & Biosimilars","CRO & CDMO Services","Rare Disease Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-13T17:15:11Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":0,"expected_fill_days":56,"reasons":["conf:0","win:early"],"computed_at":"2026-10-14T05:54:28Z"},"pay":null,"html_url":"https://alion.io/job/sobi-external-quality-operations-manager-2","json_url":"https://alion.io/job/sobi-external-quality-operations-manager-2.json","meta":{"generated_at":"2026-10-14T05:54:28Z","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":7489,"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":4965},"rest":"https://alion.io/mcp/rest/get_company?id=4965"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fsobi-external-quality-operations-manager-2"},{"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%2Fsobi-external-quality-operations-manager-2"},{"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%2Fsobi-external-quality-operations-manager-2"},{"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/sobi-external-quality-operations-manager-2\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fsobi-external-quality-operations-manager-2"}]}