{"id":436288,"url":"https://alion.io/job/oche-ssociate-anager-mp-mpfujingri","title":"GMP副经理orGMP高级专员","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":86,"open_postings":224,"ghost_share":0.04,"stale_share":0.612,"repost_share":0.098,"time_to_fill_p50_days":19,"computed_at":"2026-11-01T06:10:25Z"}},"role":"Biotech","role_family":"Biotech","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"],"countries":["CN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":40000,"max_usd":82000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":543},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GMP","optional":false}],"status":"live","first_seen_at":"2026-06-11T00:00:00Z","employer_posted_date":"2026-10-21","last_verified_at":"2026-11-01T06:49:29Z","board_verified":true,"closed_at":null,"days_open":143,"trust":{"level":"stale","repost_count":1,"flags":["stale"],"days_open":143},"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\nPrinciple Roles & Responsibilities / Accountabilities\nEngineering Project Support and Operation Readiness:\nCollaborate with cross-functional teams to implement GMP-related systems, processes, and workflows for the production department.\nDevelop and implement GMP training programs tailored to production staff, aligned with corporate quality policies and regulatory requirements.\nEstablish the deviation management and CAPA processes in manufacturing for handling non- conformances effectively and ensuring timely resolutions.\nImplement a robust change control process, ensuring GMP compliance and proper documentation of changes in the production environment.\nParticipate in the preparation for facility qualification audits and regulatory inspections, ensuring that all systems and practices meet GMP standards.\nLead consumable materials/service introduction and track the status to ensure to meet the manufacturing requirement.\nSupport the development of GMP documentation including SOPs, validation protocols, and project-specific documentation for compliance.\nPerform other duties as assigned.\nRoutine Operation:\nEnsure routine operation in compliance with Roche’s GMP/SHE and regulation requirements.\nServe as the primary interface between the production department and QA/Compliance teams for GMP-related matters.\nManage ongoing GMP training programs, ensuring production personnel are regularly updated on GMP and compliance requirements.\nOversee the timely identification, investigation, and resolution of deviations, ensuring proper execution of CAPAs to avoid recurrence.\nEvaluate and coordinate changes within the production department, ensuring proper implementation and documentation in line with regulatory requirements.\nAct as the production department’s primary liaison during internal and external audits, ensuring inspection readiness and addressing observations.\nMonitor GMP compliance in daily operations, identifying gaps and implementing corrective actions.\nProactively identify areas for improvement in GMP operations, driving initiatives to enhance quality and productivity while maintaining compliance.\nPerform other duties as assigned.\nQualification and Experience\nEducation/Qualifications\nBachelor’s Degree (Pharmaceutical / Biological is preferred) and above.\nJob Required Competencies\n5 or more years’ operation experience in GMP compliance roles in the injection pharmaceutical industry, MNC Bio-pharma preferred.\nExperienced in strategic projects of facility including design, commissioning & qualification is preferred.\nStrong knowledge of cGMP and regulations relevant to the pharmaceutical industry, especially in the biological industry.\nHands-on experience in deviation handling, CAPA management, change control, and audit preparation is required.\nFamiliarity with compliance tools and systems for managing training, deviations, and CAPAs.\nFluent communications skills in English is preferred and the ability to effectively communicate, collaborate, and foster positive interactions with team members and stakeholders.\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":4156,"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":true}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Diagnostic Tests & IVD","Biologics & Biosimilars","Oncology Therapeutics"],"lifecycle":[{"event":"open","at":"2026-09-06T07:04:41Z"},{"event":"reopen","at":"2026-10-21T09:30:04Z"}],"visa":[],"liveness":{"score":4,"band":"cold","label":"Long shot","p_open":1,"p_active":0.151,"p_room":0.28,"age_days":143,"expected_fill_days":19,"reasons":["conf:11","stale_co","velocity","win:tail","crowd:brand"],"computed_at":"2026-11-01T06:10:25Z"},"pay":null,"html_url":"https://alion.io/job/oche-ssociate-anager-mp-mpfujingri","json_url":"https://alion.io/job/oche-ssociate-anager-mp-mpfujingri.json","meta":{"generated_at":"2026-11-01T09:43:57Z","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":15046,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-02T00:00:00Z"}},"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%2Foche-ssociate-anager-mp-mpfujingri"},{"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%2Foche-ssociate-anager-mp-mpfujingri"},{"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%2Foche-ssociate-anager-mp-mpfujingri"},{"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/oche-ssociate-anager-mp-mpfujingri\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Foche-ssociate-anager-mp-mpfujingri"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":436288}},{"tool":"search_jobs","arguments":{"company":"roche.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":436288},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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