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Quality Operations Manager

Astrix, Ridgefield, NJ, United States


Overview
Pay Rate Low: 125000 | Pay Rate High: 155000

Our client, a personal care manufacturer, is seeking a

Plant Quality Manager

to provide both strategic direction and hands-on leadership across all quality functions within a high-volume, FDA-regulated OTC manufacturing facility.

Role
Title:

Plant Quality Manager - OTC Manufacturing

Salary:

$125,000 – $155,000 + annual bonus

Location:

Ridgefield, NJ (Fully Onsite)

Relocation Assistance: Available

Schedule
Schedule:

Monday–Friday 7:30am start time

About The Role
This role is responsible for ensuring GMP compliance, strengthening the site’s quality systems, and fostering a strong culture of quality and operational excellence. This is a highly visible leadership position requiring a hands-on professional who can work directly on the production floor, rebuild and develop teams, and drive continuous improvement initiatives in a fast-paced manufacturing environment.

Key Responsibilities

Lead Quality Assurance, Quality Control Labs, Document Control, Validation, and Complaint Management teams

Oversee and enhance the site’s Quality Management System (QMS) in alignment with FDA and corporate standards

Serve as the site quality leader during FDA and customer inspections; ensure continuous inspection readiness

Drive resolution of compliance issues and manage CAPAs effectively

Collaborate cross-functionally with Operations, Engineering, and R&D on investigations, change control, and validation activities

Oversee batch record review, product release, deviations, and investigations

Partner with customers and internal stakeholders to meet quality and compliance expectations

Analyze quality metrics and implement improvements to drive performance

Coach, mentor, and develop a high-performing quality team

Represent site quality leadership in executive-level discussions

Contribute to broader quality strategy and site expansion initiatives

Qualifications
Education

Bachelor’s degree in Chemistry, Microbiology, Pharmacy, Chemical Engineering, or a related field

Masters degree is a plus

Experience

10+ years in FDA-regulated environments (OTC, pharmaceutical, or personal care manufacturing)

10+ years leading FDA inspections and remediation efforts

Experience with topical formulations strongly preferred

Proven leadership experience in a manufacturing environment

INDBH

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