Garonit Pharmaceutical
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.
Seniority level Director
Employment type Full‑time
Job function Quality Assurance
#J-18808-Ljbffr
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.
Seniority level Director
Employment type Full‑time
Job function Quality Assurance
#J-18808-Ljbffr