{"id":2839225,"url":"https://alion.io/job/astrazeneca-associate-director-external-quality-2","title":"Associate Director External Quality","company":{"id":13195,"name":"AstraZeneca","domain":"astrazeneca.com","url":"https://alion.io/company/astra-zeneca","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"A","score":92,"open_postings":122,"ghost_share":0,"stale_share":0.492,"repost_share":0.057,"time_to_fill_p50_days":20,"computed_at":"2026-10-25T05:49:26Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"head","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Wuxi, China"],"countries":["CN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":44000,"max_usd":108000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":779},"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GMP","optional":false},{"name":"Veeva","optional":false}],"status":"live","first_seen_at":"2026-10-19T08:21:58Z","employer_posted_date":"2026-10-19","last_verified_at":"2026-10-25T00:12:34Z","board_verified":true,"closed_at":null,"days_open":5,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":5},"description":"Typical Accountabilities\nResponsible for Quality Supplier Management including but not limited to: Annual Assessments; Quality Agreements; trending and reporting of data; assessing, reviewing and improving quality systems at Suppliers; attendance at Quality and Business Review Meetings.\n\nMaintains a high level of understanding of relevant production processes and quality systems.\n\nPerforms the Quality review and/or approval of the following cGMP documentation for their Suppliers:\nChange Requests\n\nProduct Quality Reviews or Supplier Quality Review (DMS)\n\nCMC documentation (ERV) associated with changes or product establishment at Suppliers\n\nDevelopment and technology transfer documentation, along with Director, Supply and Quality Systems, EQ\n\nQuality Investigations (Deviations, Product Quality Complaints)\n\nValidation Plans, Protocols and Reports\n\nCollaborates with and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systems\n\nResponsible for quality issues escalation and resolution at the Suppliers, to ensure right product at the right time is delivered into the Product Supply Chain.\n\nProactively ensures GMP and regulatory compliance during the planning, execution and closeout phases of projects at their Supplier(s).\n\nAs a member of a Supplier Management team, responsible for supporting cost saving initiatives, value creation, performance standards, continuous improvements, and issue resolutions at their Supplier(s)\n\nCollaborates with, and influences, other PCO/assigned area members to facilitate process improvements and risk assessments; benchmarks internal and external Quality practices to identify innovative efficient and effective practices\n\nStays abreast of evolving regulatory compliance practices and recommends implementation strategies to EQ/AZ site leaders\n\nCollaborates in data analysis and report creation on quality metrics and key performance indicators\n\nDevelops and maintains effective business relationships with Suppliers\n\nSpecific to the support and management of External Quality QMS, may be responsible for one or more of the following:\n\nSite Stability Management System.\n\nManages quality data and records in relevant quality management support systems (e.g. Veeva Vault etc) as required.\n\nAssist in the production of, or contribution to, AZ quality documentation (including EQ/EQ SOPs, Q & C Manual Procedures, etc)\n\nParticipates in EQ self-inspection program, auditing processes and procedures.\n\nDevelops and maintains a high level of understanding of the technical production process and quality systems being utilized within the External Supply & Manufacturing (ESM) and External Quality (EQ) organisations\n\nAccountable for Quality decision-making; works directly with the Supplier Management leader and other team members to deliver objectives\n\nEnsures compliance with all GMP Compliance and Regulatory requirements by providing proper coaching, mentoring and consultation to the Supplier Management Team\n\nProvides functional direction as required.\n\nPlanning for, supporting and participating in Regulatory Agency inspections of their Suppliers and AZ sites (regarding Quality management for supply of external materials to the Sites)\n\nAs needed, perform Quality Audits within their technology area, as a Guest Auditor on the GQA lead audit team.\n\nServe as EQ representative on Issue Management Teams\n\nProvide expert Quality input to NPI, Asset Strategy and/or Value Delivery projects. This includes identifying and assessing Suppliers, establishing Supplier’s way of working with External Quality and supporting the Supplier through to regulatory approval.\n\nLiaise with Suppliers to ensure successful delivery of projects\n\nMake decisions and advise the Supplier Management Team regarding quality and pharmaceutical technology issues within their area of expertise.\n\nEducation, Qualifications, Skills and Experience\nEssential ：\nBachelor degree in a science / technical field such as Pharmacy, Biology, Chemistry or Engineering (Note: there may be specific additional requirements depending on the regulations in each country). Proven broad experience in either the pharmaceutical operations environment or pharmaceutical Quality Assurance role\n\nStrong demonstrated knowledge of cGMPs, Quality Systems and the pharmaceutical supply chain environment. Also strong understanding of industry standards such as Pharmacopeia, ISO standards, etc.\n\nExcellent oral and written communication skills [English and local language(s)]\n\nDemonstrated experience working cross-functionally and managing significant improvement initiatives (e.g. project management skills)\n\nStrong problem solving skills\n\nStrong negotiating/influencing skills\n\nAbility to work independently under his/her own initiative.\n\nAbility to travel nationally and internationally as required up to 25% of their time.\n\nDesirable ：\nExperience working in a PCO/PET organization or Lean/Six Sigma training.\n\nMulti-site / multi-functional experience\n\nProven experience in Quality Assurance or combination of Quality and Technical\n\nMasters Degree in Quality Assurance/Regulatory Affairs or other advanced scientific field\n\nDate Posted\n19-10月-2026Closing Date\n29-11月-2026AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.","description_format":"text","description_chars":5869,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"master","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Oncology Therapeutics","Rare Disease Therapeutics","Cardiometabolic Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-19T08:21:58Z"}],"visa":[],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":5,"expected_fill_days":20,"reasons":["conf:5","velocity","win:early","comp:brand"],"computed_at":"2026-10-25T05:49:26Z"},"pay":null,"html_url":"https://alion.io/job/astrazeneca-associate-director-external-quality-2","json_url":"https://alion.io/job/astrazeneca-associate-director-external-quality-2.json","meta":{"generated_at":"2026-10-25T07:35:31Z","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":10639,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-26T00:00:00Z"}},"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":13195},"rest":"https://alion.io/mcp/rest/get_company?id=13195"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fastrazeneca-associate-director-external-quality-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%2Fastrazeneca-associate-director-external-quality-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%2Fastrazeneca-associate-director-external-quality-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/astrazeneca-associate-director-external-quality-2\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fastrazeneca-associate-director-external-quality-2"}]}