Head of Quality

2 weeks ago


Fairfield NJ, United States Garonit Pharmaceutical Full time $200,000 - $300,000 per year

Head of Quality

Onsite in
Fairfield, NJ

We're seeking an experienced Head of Quality to oversee all Quality and Regulatory functions — ensuring compliance with FDA, cGMP, and global regulatory standards. This is a critical leadership role responsible for setting the company's quality vision, overseeing ANDA/NDA submissions, managing inspections, and leading both QA and QC operations.

What You'll Do

  • Lead all aspects of Quality Assurance (QA), Quality Control (QC), and Quality Systems.
  • Develop, implement, and maintain a comprehensive Quality Management System (QMS) aligned with FDA and global requirements.
  • Oversee ANDA, NDA, and international regulatory submissions and lifecycle management.
  • Ensure inspection readiness and lead FDA and internal audits.
  • Direct CAPA, deviations, batch record review, and change control processes.
  • Partner cross-functionally with Manufacturing, R&D, and Operations to embed quality across all functions.
  • Provide strategic leadership on compliance, regulatory strategy, and continuous improvement.
  • Represent Garonit Pharma in regulatory communications and inspections.

What You'll Bring

  • Bachelor's or Master's degree in a scientific discipline (Pharmacy, Chemistry, Engineering, or Life Sciences).
  • 15+ years of progressive experience in pharmaceutical Quality and Regulatory leadership.
  • Proven expertise with cGMP, 21 CFR, ICH guidelines, and ANDA/NDA submissions.
  • Demonstrated success leading quality organizations through audits, inspections, and product approvals.
  • Excellent leadership, communication, and decision-making skills.
  • Strategic thinker with meticulous attention to detail and a passion for quality excellence

Why Garonit Pharma

  • Lead the quality and compliance strategy for a growing, innovation-driven pharma company.
  • Build and shape the Quality organization
  • Collaborate with experienced executives committed to scientific and operational excellence.
  • Competitive executive compensation and growth potential in a high-impact leadership role.

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