Manager, Global Quality Compliance

SUN PHARMA · Princeton, New Jersey, United States

Location

Princeton

Job Type

Full-time

Posted

July 04, 2026

Job Description

Job Summary
Manage overall batch review of sterile and OSD manufacturing/packaging records, certificates of analysis/compliance and all related supporting documentation (i.e. documentation review, SOP compliance, instrument preventive maintenance/calibration/qualification/validation as per good manufacturing practices/good documentation requirements and ALCOA++ principles). This role will be an individual contributor with expert level experience in manufacturing investigations from FDA approved facilities that make sterile and OSD products. 
Area Of Responsibility
Subject matter expert (SME) understanding of sterile manufacturing and packaging.

Leads the review of sterile and OSD manufacturing/packaging records from a Global Quality perspective.

QA SME for manufacturing (Sterile & OSD), environmental monitoring, microbiology, media-fill & packaging Investigations and related CAPAs.

Successful experience with FDA...
        

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