More jobs:
Site Quality Head
Job in
Hamilton, Atlantic County, New Jersey, USA
Listed on 2026-10-31
Listing for:
Inflow Partnership
Full Time
position Listed on 2026-10-31
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist
Job Description & How to Apply Below
Our client is a sterile pharmaceutical manufacturing company looking for a Site Quality Head for their New Jersey site, currently in a start-up / scale-up phase.
This role will report directly to the Chief Technical Officer.
Responsibilities:
- Build and lead the site Quality Management System (QMS) for a new sterile injectable manufacturing facility, ensuring compliance with FDA, EMA, ICH, EU Annex 1 and cGxP requirements
- Lead regulatory and inspection readiness, including pre-approval inspections, audits, quality risk management and critical quality decisions
- Establish and oversee key quality processes including batch release, deviations, CAPA, change control, complaints and product disposition
- Build and develop the site Quality organisation across QA, QC, Microbiology and Document Control, embedding a strong culture of patient safety, compliance and continuous improvement
- Act as the site’s senior quality authority, partnering with cross-functional teams and serving as the primary interface with regulators, customers and external auditors
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