Jobs / United States / Pfizer INC
Manager, GMP Audits
Pfizer INC · 🇺🇸 2 Locations
Sponsorship verdict
Sponsorship possible
One solid signal, not two — worth applying, and worth asking about sponsorship early.
- Employer is on a government sponsor recordThe US Department of Labor certified 40 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 9 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
- The posting doesn’t mention sponsorshipSilence isn’t a refusal — ask the recruiter before investing much time.
- No salary bar for this routeH-1B has no fixed salary bar: the employer must pay at least the prevailing wage for the role and area. Cap-subject employers enter a lottery weighted by wage level. Source: https://www.federalregister.gov/documents/2025/12/29/2025-23853/weighted-selection-process-for-registrants-and-petitioners-seeking-to-file-cap-subject-h-1b, rules effective 2026-02-27.
- What Pfizer INC paid sponsored hires in similar roles3 certified filings for “SENIOR MANAGER, STATISTICAL PROGRAMMING” (Statisticians) in CA: $171k–$214k, median $208k. Most were filed at wage level IV (67%) — 4 lottery entries, ≈61% projected selection odds for cap-subject employers. Source: US Department of Labor LCA disclosure data (Oct 2025 – Jun 2026).
- Confirmed live todayWhen a source last listed this job as open.
US H-1B: cap-subject employers enter a lottery weighted by wage level — Level I gets 1 entry, Level IV gets 4 (DHS projected selection odds ≈15% at Level I to ≈61% at Level IV). Universities and non-profit research employers are cap-exempt. The $100,000 fee for new petitions from abroad is currently blocked by a court order (appeal pending).
A verdict summarises public evidence; it is not legal advice and never a guarantee — the employer and the immigration authority decide. Sign in to factor in where you can already work.
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Sponsor Radar — Pfizer INC
The US Department of Labor certified 40 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 9 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
Past sponsorship or register membership never guarantees sponsorship for this vacancy or for you. Full Sponsor Radar for Pfizer INC →
About the role
POSITION DESCRIPTION Identifying Position Information POSITION TITLE: (title reflected in Outlook and Pfizer Org Chart) Manager, GMP GDP Auditor REPORTS TO: (Manager’s Name) Director / Sr. Director, GMP GDP Audit Team Lead DATE COMPLETED/ REVIEWED 8/11/2025 DIVISION/BUSINESS LINE: Pfizer Global Supply & Quality SUB DIVISION: DEPARTMENT: Regulatory Quality Assurance LOCATION(S): (indicate all possible locations) Primary: Global – Any Pfizer site Is this a legacy Hospira position? ☐ Yes Other: Remote APPROVAL FROM SITE LEADERSHIP: (required for Cambridge Site) N/A ROLE DETAILS ROLE SUMMARY ROLE SUMMARY Regulatory 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. ROLE RESPONSIBILITIES ROLE RESPONSIBILITIES • Independently 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 • Leverages responsible use of AI tools to support targeted audit preparation and execution • May engage with more complex audits including process audits or serve as a reviewer of low complexity, outsourced audits • Supports and executes on quality programs related to functional areas, specific vendor entities and/or assessments • Has 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 • Works with RQA colleagues on cross GxP audit plans as required • Ability to manage multiple stakeholders to synthesize feedback and take action with support from Manager • undefined QUALIFICATIONS • undefined BASIC QUALIFICATIONS • BS (or equivalent), preferably in pharmaceutical or natural sciences, or equivalent • Demonstrates advanced knowledge and understanding of global regulations (e.g., FDA, ICH, PIC’s, EMA, HC, ANVISA, TGA) and international standards (e.g., ISO, WHO) • Applies human oversight, professional judgment, and source verification when using AI tools to support audit planning, execution, reporting, and follow-up • Demonstrates willingness to adopt new audit technologies and contribute to continuous improvement of digital audit workflows and methodologies • Demonstrates willingness to adopt new audit technologies and contribute to continuous improvement of digital audit workflows and methodologies. • Demonstrates comprehensive working knowledge of business concepts and quality operations • Ability to think critically to identify and assess areas of greatest risk and develop a strategic approach to audit based on compliance and business knowledge • Understands quality and auditing frameworks and application • Exhibits proficient organizational and project management skills •