Plant Quality Manager

Plant Quality Manager - OTC Manufacturing

About The Role

The Plant Quality Manager provides strategic and hands-on leadership for all quality functions at a high-volume, FDA-regulated OTC manufacturing facility. 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.

• Salary: $125,000 – $155,000 annual bonus
• Location: Ridgefield, NJ (Fully Onsite)
• Relocation Assistance: Available
• Schedule: Monday–Friday 7:30am (start time)
  
  

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
  
  

***This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!***

INDBH