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The Judge Group

Sr Quality Compliance Manager (1071336)

The Judge Group, Florham Park, New Jersey, us, 07932

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Sr Quality Compliance Manager (1071336)

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Sr Quality Compliance Manager (1071336)

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The Judge Group Get AI-powered advice on this job and more exclusive features. Location:

Florham Park, NJ

Salary:

$130,000.00 USD Annually - $155,000.00 USD Annually

Description:

Our client is currently seeking a Sr Quality Compliance Manager - Sterile Products. This is a permanent, direct hire, hybrid role.

Overview

Lead quality oversight for multiple sterile products & medical devices throughout their lifecycle. Serve as a key liaison with external business partners/CMOs. Ensure compliance with Quality Management System.

Responsibilities

Oversee documentation review & approval, including validation reports, manufacturing records, and investigations. Manage commercial product release, including US and ROW markets. Support regulatory inspections, audits, and quality agreements. Lead technical transfers, process validation, and troubleshooting. Track and analyze key performance metrics for external partners. Maintain change control records and ensure compliance with regulatory guidelines.

Qualifications

BS in Pharmacy, Chemistry, Microbiology, or Biology; 15+ years in Pharma Quality. Expertise in GMP regulations, medical device compliance, and sterile manufacturing. Strong leadership, technical writing, and communication skills. Ability to manage multiple projects and work independently.

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Contact:

jgood@judge.com

This job and many more are available through The Judge Group. Find us on the web at www.judge.com Seniority level

Seniority level Mid-Senior level Employment type

Employment type Full-time Job function

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