{"id":4174212,"url":"https://alion.io/job/biontech-associate-director-global-development-quality-assurance","title":"Associate Director, Global Development Quality Assurance","company":{"id":140,"name":"BioNTech","domain":"biontech.com","url":"https://alion.io/company/biontech","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":null},"role":"Leadership","role_family":"Leadership","seniority":"head","employment_type":null,"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":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Good Clinical Practice","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-11-12T15:32:39Z","employer_posted_date":"2026-11-12","last_verified_at":"2026-11-12T23:33:18Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"Shanghai, China | full time | Job ID: 11919\nAbout the role:\nAs Associate Director, Clinical Quality Assurance Compliance, you will help ensure clinical development activities meet quality standards and regulatory requirements. Your work supports BioNTech’s mission by helping protect patient safety, rights and well-being throughout clinical research.\nYou’ll partner with clinical trial teams and colleagues across a global, cross-functional environment. By applying proactive, risk-based quality oversight, you’ll help trials stay inspection-ready and support continuous improvement across clinical development.\nYour contribution:\nShape and implement proactive, risk-based quality strategies for assigned clinical trials, applying Good Clinical Practice and Quality by Design principles\nAdvise trial teams on quality risks, deviations and investigations, and guide robust corrective and preventive actions through to effectiveness checks\nProvide quality input to trial decisions and documentation, and maintain clear dashboards that track risks, findings, actions and key milestones\nCoordinate inspection readiness, including preparation of narratives, sites, records and mock inspections, and support health authority inspections and follow-up\nOversee audit planning and follow-up, and work with external partners to support quality agreements and compliance\nContribute to quality initiatives, procedures and a culture of transparency, speak-up and continuous improvement across clinical development\nA good match:\nBachelor’s degree in medicine or another life science; an advanced degree is preferred\nExperience in Good Clinical Practice, clinical development quality assurance or quality management, including regulatory inspections, quality systems or training\nKnowledge of drug development regulations and guidance, including requirements from NMPA, FDA, EMA and ICH\nExperience supporting escalations and corrective and preventive actions, and working with external partners such as contract research organizations\nFluent English, with strong written and verbal communication skills; confident with Microsoft Office and electronic quality management systems\nCollaborative and clear in a global, cross-functional environment, with the judgment to address quality concerns proactively\nYour benefits:\nBioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and experience.\nNote: The availability, eligibility and design of the listed benefits may vary depending on the location. The final requirements for the individual use of our benefits are based on the company's internal policies and applicable law.\nHow to apply:\nApply now by sending us your application documents including Curriculum Vitae, copy of ID, copies of degree certificates and professional certificates, motivation letter as well as your contact details via our online form.\nPlease note:\nOnly applications sent via our online form shall be considered. By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider ‘HireRight’. You will be informed accordingly by your BioNTech-Recruiter.\nWe are looking forward receiving your application.","description_format":"text","description_chars":3569,"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":"Advanced (C1)","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Cell & Gene Therapy","Vaccines","Oncology Therapeutics","Infectious Disease Therapeutics"],"lifecycle":[{"event":"open","at":"2026-11-12T15:32:39Z"}],"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":27,"reasons":["conf:5","win:early"],"computed_at":"2026-11-13T04:33:47Z"},"pay":null,"html_url":"https://alion.io/job/biontech-associate-director-global-development-quality-assurance","json_url":"https://alion.io/job/biontech-associate-director-global-development-quality-assurance.json","meta":{"generated_at":"2026-11-13T04:33:47Z","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":9669,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-14T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"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":140},"rest":"https://alion.io/mcp/rest/get_company?id=140"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fbiontech-associate-director-global-development-quality-assurance"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"free","price":{"credits":0,"usd":0},"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%2Fbiontech-associate-director-global-development-quality-assurance"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"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%2Fbiontech-associate-director-global-development-quality-assurance"},{"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/biontech-associate-director-global-development-quality-assurance\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fbiontech-associate-director-global-development-quality-assurance"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4174212}},{"tool":"search_jobs","arguments":{"company":"biontech.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4174212},"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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