{"id":2933782,"url":"https://alion.io/job/pfizer-manager-gmp-audits-3","title":"Manager, GMP Audits","company":{"id":3480,"name":"Pfizer","domain":"pfizer.com","url":"https://alion.io/company/pfizer","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":86,"open_postings":22,"ghost_share":0,"stale_share":0.773,"repost_share":0,"time_to_fill_p50_days":13,"computed_at":"2026-10-25T05:49:26Z"}},"role":"Legal","role_family":"Legal","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":["Wuxi, China","China"],"countries":["CN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":40000,"max_usd":111000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":2821},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Outlook","optional":false}],"status":"live","first_seen_at":"2026-08-28T00:00:00Z","employer_posted_date":"2026-08-28","last_verified_at":"2026-10-24T01:07:44Z","board_verified":true,"closed_at":null,"days_open":58,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":58},"description":"POSITION DESCRIPTION\nIdentifying Position Information\nPOSITION TITLE:\n(title reflected in Outlook and Pfizer Org Chart)\nManager, GMP GDP Auditor\nREPORTS TO: (Manager’s Name)\nDirector / Sr. Director, GMP GDP Audit Team Lead\nDATE COMPLETED/ REVIEWED\n8/11/2025\nDIVISION/BUSINESS LINE:\nPfizer Global Supply & Quality\nSUB DIVISION:\nDEPARTMENT:\nRegulatory Quality Assurance\nLOCATION(S): (indicate all possible locations)\nPrimary:\nGlobal - Any Pfizer site\nIs this a legacy Hospira position?\nYes\nOther:\nRemote\nAPPROVAL FROM SITE LEADERSHIP: (required for Cambridge Site)\nN/A\nROLE DETAILS\nROLE SUMMARY\nROLE SUMMARY\nRegulatory Quality Assurance (RQA) is an independent Quality audit function accountable to identify risks and non-compliance associated with Pfizer’s GxP regulated operations. Within RQA, the GMP GDP Audit function is responsible for performing GMP /GDP audits of Pfizer facilities, contract manufacturers, suppliers and GMP/GDP service providers involved in the manufacturing, packaging, testing and distribution of APIs, clinical trial materials and commercial biopharmaceutical products worldwide. The RQA GMP GDP Audit function is accountable to ensure Pfizer manufacturing operations are compliant with all applicable global GMP/GDP regulations/standards and Pfizer Quality Standards. The RQA GMP GDP Audit function is required to understand GMP /GDP regulations worldwide and apply this expertise when performing audits, to provide assurance against regulator’s interpretation and expectations for compliance with cGMP/GDP requirements.\nROLE RESPONSIBILITIES\nROLE RESPONSIBILITIES\nIndependently plans/leads more complex audits of material suppliers, service providers and Pfizer Country Offices, participates in audits of low complexity commercial/clinical manufacturing sites and contracts manufacturers, performs initial and routine audits, and manages/leads with minimum oversight\nLeverages responsible use of AI tools to support targeted audit preparation and execution\nMay engage with more complex audits including process audits or serve as a reviewer of low complexity, outsourced audits\nSupports and executes on quality programs related to functional areas, specific vendor entities and/or assessments\nHas GMP working knowledge and is called upon to resolve issues based on knowledge of relevant SOPs (Standard Operating Procedures), GMP GDP regulations/standards, as well as local regulations and standards\nWorks with RQA colleagues on cross GxP audit plans as required\nAbility to manage multiple stakeholders to synthesize feedback and take action with support from Manager\nundefined\nQUALIFICATIONS\nundefined\nBASIC QUALIFICATIONS\nBS (or equivalent), preferably in pharmaceutical or natural sciences, or equivalent\nDemonstrates advanced knowledge and understanding of global regulations (e.g., FDA, ICH, PIC’s, EMA, HC, ANVISA, TGA) and international standards (e.g., ISO, WHO)\nApplies human oversight, professional judgment, and source verification when using AI tools to support audit planning, execution, reporting, and follow-up\nDemonstrates willingness to adopt new audit technologies and contribute to continuous improvement of digital audit workflows and methodologies\nDemonstrates willingness to adopt new audit technologies and contribute to continuous improvement of digital audit workflows and methodologies.\nDemonstrates comprehensive working knowledge of business concepts and quality operations\nAbility to think critically to identify and assess areas of greatest risk and develop a strategic approach to audit based on compliance and business knowledge\nUnderstands quality and auditing frameworks and application\nExhibits proficient organizational and project management skills\nDemonstrates technical writing skills\nAbility to identify trends within data and apply insights to make recommendations\nActively identifies areas to assess for greater risk to support senior auditor positions in driving outcomes\nAbility to synthesize information and draw conclusions\nSuggests new audit techniques and approaches, and operationalizes to improve the audit system\nSpecializes in at least one conventional technology (e.g., API, solid oral dosages)\nundefined PREFERRED QUALIFICATIONS 5-7 years of experience (operational or auditing preferred)Exhibits working knowledge of data analytics and interpretation capabilitiesExpertise in vendor audits plus 1+ technology area (MDCP, sterile biologics, small molecules, GDP’s)Ability to function autonomously in a matrix model and in a team environmentundefined\nPHYSICAL/MENTAL REQUIREMENTS\nPHYSICAL/MENTAL REQUIREMENTS\nPrimarily a field-based position which includes walking, observing (physically and electronically) and lifting to assess quality and compliance risks.\nNON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS\nNON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS\nAbility to travel up to 40% of the time, including domestic and international traveling.\nOTHER INFORMATION\nOTHER INFORMATION\nN/A\nORGANIZATIONAL RELATIONSHIPS\nProvide the primary groups or key role(s) that this role will have interaction with as a regular part of the role responsibilities. Include any external interactions as appropriate.\nCollaborate with colleagues across RQA and auditees from different functional lines within Pfizer and/or vendors\nRESOURCES MANAGED\nFinancial Accountability\nIndicate the Average Budget or Revenue accountability, as applicable.\nN/A\nSupervision\nIndicate the typical number of Colleagues managed; include direct & indirect reports and matrix responsibility. Note if direct reports are people managers or individual contributors. Indicate additional resources (i.e. contingent workers) managed, as applicable.\nNo direct and/or indirect reports are managed by this position\nWork Location Assignment: Remote\nPfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.\nTo learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.\n\nQuality Assurance and Control","description_format":"text","description_chars":6159,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Oncology Therapeutics","Infectious Disease Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-20T15:29:33Z"}],"visa":[],"liveness":{"score":9,"band":"cold","label":"Long shot","p_open":1,"p_active":0.315,"p_room":0.28,"age_days":58,"expected_fill_days":13,"reasons":["conf:28","stale_co","velocity","win:tail","crowd:brand"],"computed_at":"2026-10-25T05:49:26Z"},"pay":null,"html_url":"https://alion.io/job/pfizer-manager-gmp-audits-3","json_url":"https://alion.io/job/pfizer-manager-gmp-audits-3.json","meta":{"generated_at":"2026-10-25T08:35:26Z","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":12206,"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":3480},"rest":"https://alion.io/mcp/rest/get_company?id=3480"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fpfizer-manager-gmp-audits-3"},{"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%2Fpfizer-manager-gmp-audits-3"},{"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%2Fpfizer-manager-gmp-audits-3"},{"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/pfizer-manager-gmp-audits-3\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fpfizer-manager-gmp-audits-3"}]}