Director of Sterile Quality & Compliance

Amneal Pharmaceuticals LLC; Town of Brookhaven (NY); On-site; USD 190,000 - 200,000; Full time

Benefits offered by this job

Short-term incentive

Long-term incentive (RSUs)

Comprehensive benefits + 401(k) match

Job summary

Amneal Pharmaceuticals LLC seeks a Director of Quality Management for Sterile Manufacturing to lead end-to-end quality efforts from concept to commercial launch. You will oversee TS, BFS, PFS, and IV Bag operations, ensuring all systems, documentation, and processes meet FDA, EU GMP, ICH, and USP standards.

You will build a high-performing Sterile Quality organization, drive risk-based decisions, and ensure rapid escalation and issue resolution while maintaining independence and regulatory

Qualifications

• 12+ years in progressive pharmaceutical QA/QM within FDA-regulated GMP environments.
• 7+ years supporting sterile drug-product manufacturing and/or facility start-up.
• 5+ years quality oversight of capital projects from design to validation.

Responsibilities

• Provide independent Quality leadership across sterile manufacturing programs.
• Oversee qualification/validation lifecycles for facilities, equipment, and systems.
• Ensure regulatory readiness, inspections, and CAPA programs are addressed.
• Lead the Sterile Quality organization and staffing plans.
• Maintain ongoing quality oversight after commercial launch and during operations.

Skills

Quality leadership

GMP knowledge

Regulatory readiness

Project leadership

Education

Bachelor's Degree in Pharmaceutical Sciences or related

Master's Degree in a relevant discipline

Job description

Amneal Pharmaceuticals LLC seeks a Director of Quality Management for Sterile Manufacturing to lead end-to-end quality efforts from concept to commercial launch. You will oversee TS, BFS, PFS, and IV Bag operations, ensuring all systems, documentation, and processes meet FDA, EU GMP, ICH, and USP standards.

You will build a high-performing Sterile Quality organization, drive risk-based decisions, and ensure rapid escalation and issue resolution while maintaining independence and regulatory