{"id":3150689,"url":"https://alion.io/job/roche-quality-assurance-expert","title":"Quality Assurance Expert","company":{"id":13531,"name":"Roche","domain":"roche.com","url":"https://alion.io/company/roche","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":87,"open_postings":188,"ghost_share":0,"stale_share":0.681,"repost_share":0.037,"time_to_fill_p50_days":19,"computed_at":"2026-10-23T05:54:15Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","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":["Shanghai, China","Beijing, China"],"countries":["CN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":32000,"max_usd":72000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":7932},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false},{"name":"Agile","optional":true}],"status":"live","first_seen_at":"2026-10-23T12:12:16Z","employer_posted_date":"2026-10-23","last_verified_at":"2026-10-23T20:21:47Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.\nThe Position\nObjectives and Scope of Position:\n•Strategy/Execution Ratio: You will operate with a balanced focus between strategy and execution (50% Strategy / 50% Execution), driving long-term goals and executing business processes.\nDesign and deliver Quality Strategies and conclusions for assigned entities/processes.\nContribute to the delivery of PDQ work and the development of PDQ processes.\nLead and participate in PDQ goals and initiatives and support regulatory authority inspections.\nApply a risk-based approach to Quality Assurance strategies based on the Critical to Quality (CtQ) framework.\nMentor and support the development of Quality Leads within the team.\nSummary of Main Responsibilities:\n•Design and Implementation of Quality Strategies\nEstablish relationships with business stakeholders and lead the development of molecule/product/process/affiliate-level approaches with appropriate measures (CtQ Factors).\nAnalyze quality data to identify trends and risks, providing insights to business partners.\n•Delivery of Activities to Assess Quality Status\nLead and perform complex audits and quality assessments.\nSynthesize individual audit issues into systematic conclusions and present findings and associated risks to senior stakeholders, ensuring quality data fulfills regulatory requirements and supports organizational goals.\n•Demonstration of Implementation to Health Authorities\nPlay a lead role in inspection preparation and management.\nProvide training to staff and ensure relevant materials are prepared for regulatory review.\n•Execution of PDQ Goals\nLead assigned goals and initiatives and drive the development or revision of PDQ processes.\nNetworking:\nMaintain and influence partnerships with senior business stakeholders and PDQ domains.\nFacilitate cross-functional collaboration to ensure quality standards are met globally.\nCompliance:\nExpert knowledge in GxP regulations (NMPA, ICH guidance) and internal policies.\nEnsure all activities are conducted in compliance with regulatory and company requirements.\nQualification, knowledge and experience:\nMinimum Qualification:\nBachelor’s degree or equivalent in a scientific or quality-related field. Advanced degree preferred.\nMinimum Experience / Knowledge:\nSignificant experience in the pharmaceutical / biotech / medical device industry, including knowledge of the end to end development and operationalisation of products, and the associated GxP regulations and considerations (e.g., GCP, IVD/MD Regulations).\nBachelor’s degree or equivalent in a scientific or quality-related field or equivalent combination of education, training, and experience.\nAdvanced degree in referenced fields preferred.\nExtensive experience in leading GxP audits and managing complex quality projects.\nIn-depth knowledge of drug development processes and global regulatory landscapes.\nGood understanding of Information Systems, e.g., audit management and analysis reporting tools.\nUnderstanding of business operations and strategies.\nFluency in written and spoken English; bi or multi-lingual skills are desirable.\nPersonal competencies:\nStrong digital and data literacy\nSkilled in using and analyzing data to drive solutions.\nAdvanced communication and presentation skills.\nStrong stakeholder management and engagement skills.\nComfortable working with ambiguous and complex information and able to synthesize it into clear and concise points of view to influence decision-making and action-taking.\nAbility to influence with and without authority, and negotiate effective solutions.\nProven critical thinking, analytical, problem-solving, and decision-making skills.\nAbility to work effectively in an international, multicultural matrix organization and as part of agile project teams. Demonstrates effective teamwork and collaboration skills.\nAgile and creative in designing analytical solutions.\nExperienced in leading global project teams, and strong project management skills.\nStrong organizational and execution skills, and demonstrated ability to work independently and proactively.\nProven leadership and mentoring abilities.\nWho we are\nA healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.\nLet’s build a healthier future, together.\nRoche is an Equal Opportunity Employer.","description_format":"text","description_chars":5175,"description_truncated":false,"requirements":{"experience_years_min":null,"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":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Diagnostic Tests & IVD","Biologics & Biosimilars","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-23T12:12:16Z"}],"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":19,"reasons":["conf:2","win:early","comp:brand"],"computed_at":"2026-10-23T22:27:53Z"},"pay":null,"html_url":"https://alion.io/job/roche-quality-assurance-expert","json_url":"https://alion.io/job/roche-quality-assurance-expert.json","meta":{"generated_at":"2026-10-23T22:27:53Z","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":5209,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-24T00:00:00Z"}},"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":13531},"rest":"https://alion.io/mcp/rest/get_company?id=13531"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Froche-quality-assurance-expert"},{"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%2Froche-quality-assurance-expert"},{"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%2Froche-quality-assurance-expert"},{"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/roche-quality-assurance-expert\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Froche-quality-assurance-expert"}]}