What are the responsibilities and job description for the Head of Regulatory & Quality position at Garonit Pharmaceutical?
Head of Regulatory & Quality
Onsite – Fairfield, NJ
Garonit Pharma is growing, and we’re seeking a Head of Regulatory & Quality to lead all QA, QC, and Regulatory functions. This is a high-impact leadership role responsible for shaping our quality vision, ensuring global compliance, and driving regulatory strategy from development through commercialization.
What You’ll Do:
- Lead all aspects of QA, QC, and QMS to ensure compliance with FDA, cGMP, and global standards.
- Oversee ANDA/NDA and international submissions, regulatory strategy, and lifecycle management.
- Drive inspection readiness and lead FDA, EMA, and internal audits.
- Manage CAPA, deviations, and change control; champion data integrity and continuous improvement.
- Partner with R&D, Manufacturing, and Operations to embed quality into all processes.
- Serve as Garonit’s primary contact for health authorities and regulatory communications.
What You’ll Bring:
- 15 years of pharmaceutical Quality & Regulatory leadership.
- Expertise with ANDA/NDA submissions, QMS implementation, and cGMP compliance.
- Proven success leading teams through audits and global product approvals.
- Strong leadership, communication, and decision-making skills.
Why Garonit Pharma:
- Build and lead a world-class Quality & Regulatory organization.
- Partner with an innovative executive team shaping Garonit’s future.
- Competitive executive compensation and long-term growth opportunities.