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Quality Operations Manager
Job in
Ridgefield, Bergen County, New Jersey, 07657, USA
Listed on 2026-06-02
Listing for:
Astrix Inc
Full Time
position Listed on 2026-06-02
Job specializations:
-
Quality Assurance - QA/QC
Quality Control / Manager, Regulatory Compliance Specialist, Quality Engineering, Quality Technician/ Inspector
Job Description & How to Apply Below
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.
Title:
Plant Quality Manager - OTC Manufacturing
Salary: $125,000 - $155,000 + annual bonus
Location: Ridgefield, NJ (Fully Onsite) Excellent relocation package!
Relocation Assistance: Available
Schedule: Monday-Friday 7:30am (start time)
Direct Hire
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
Education
- Bachelor's degree in Chemistry, Microbiology, Pharmacy, Chemical Engineering, or a related field
- Masters degree is a plus
- 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
#LI-MG1
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