Quality Operations Manager
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At a glance
Requirements
Credentials this posting asks for.
Job overview
Astrix Technology is hiring a Quality Operations Manager. The Plant Quality Manager will provide strategic direction and hands-on leadership for all quality functions within a high-volume, FDA-regulated OTC manufacturing facility. This role ensures GMP compliance, strengthens quality systems, and fosters a strong culture of quality and operational excellence. The manager will work directly on the production floor, rebuild and develop teams, and drive continuous improvement initiatives.
Key focus areas include 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, and Serve as the site quality leader during FDA and customer inspections.
Successful candidates bring Bachelor's In Chemistry/Microbiology/Pharmacy/Chemical Engineering, 10+ Years FDA-Regulated Manufacturing, and 10+ Years Leading FDA Inspections. Important skills include GMP Compliance, Quality Systems Strengthening, Operational Excellence, Hands-On Leadership, Team Development, and Continuous Improvement.
Skills & qualifications
Skills
Qualifications
Benefits
Full job description
Quality Operations Manager
Manufacturing
Ridgefield, New Jersey, US
- Added - 20/04/2026
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.
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
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Lead Quality Assurance, Quality Control Labs, Document Control, Validation, and Complaint Management teams
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Oversee and enhance the site’s Quality Management System (QMS) in alignment with FDA and corporate standards
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Serve as the site quality leader during FDA and customer inspections; ensure continuous inspection readiness
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Drive resolution of compliance issues and manage CAPAs effectively
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Collaborate cross-functionally with Operations, Engineering, and R&D on investigations, change control, and validation activities
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Oversee batch record review, product release, deviations, and investigations
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Partner with customers and internal stakeholders to meet quality and compliance expectations
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Analyze quality metrics and implement improvements to drive performance
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Coach, mentor, and develop a high-performing quality team
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Represent site quality leadership in executive-level discussions
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Contribute to broader quality strategy and site expansion initiatives
Qualifications
Education
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Bachelor’s degree in Chemistry, Microbiology, Pharmacy, Chemical Engineering, or a related field
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Masters degree is a plus
Experience
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10+ years in FDA-regulated environments (OTC, pharmaceutical, or personal care manufacturing)
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10+ years leading FDA inspections and remediation efforts
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Experience with topical formulations strongly preferred
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Proven leadership experience in a manufacturing environment
INDBH
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We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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