Director, Sterile Quality Management & Compliance

Amneal Pharmaceuticals LLC; United States; Sur place; USD 190 000 - 200 000; Plein temps

Résumé du poste

Amneal Pharmaceuticals LLC in the United States seeks a Director of Quality Management for Sterile Manufacturing. Lead end-to-end quality oversight across sterile operations—from design through commissioning, qualification, validation, and commercial GMP manufacturing.

You will ensure FDA/EU GMP compliance, coordinate with Engineering, Validation, Manufacturing, Regulatory Affairs, and Supply Chain, and lead regulatory readiness, PPQ, and inspections.

Qualifications

• Senior quality leadership in FDA-regulated GMP environment.
• Experience with sterile drug-product manufacturing and facility start-up.
• Proven track record in QA/QM for capital projects and validation programs.

Responsabilités

• Provide independent Quality oversight for commissioning and qualification lifecycle.
• Oversee qualification/validation of sterilization and aseptic processing systems.
• Ensure Pharmaceutical Quality System is robust before GMP start-up and during operations.
• Approve GMP readiness of manufacturing, QC, and microbiology operations.
• Lead regulatory readiness and support inspections and submissions.

Connaissances

Quality leadership

Sterile manufacturing

Regulatory readiness

GMP compliance

Formation

Bachelor's Degree

Master's Degree

Description du poste

Amneal Pharmaceuticals LLC in the United States seeks a Director of Quality Management for Sterile Manufacturing. Lead end-to-end quality oversight across sterile operations—from design through commissioning, qualification, validation, and commercial GMP manufacturing.

You will ensure FDA/EU GMP compliance, coordinate with Engineering, Validation, Manufacturing, Regulatory Affairs, and Supply Chain, and lead regulatory readiness, PPQ, and inspections.