Quality Affairs Senior Director – Sterile Injectables

AMERICAN REGENT, INC.; Shirley (NY); On-site; USD 150,000 - 190,000; Full time

Job summary

American Regent, Inc. is seeking a high-level Quality leader reporting to the Senior Director of Quality, guiding the quality management system for sterile injectable manufacturing.

You will oversee laboratory operations, regulatory inspections, supplier quality, and external CMOs, ensuring cGMP compliance and robust continual improvement. You will drive KPI-based quality programs, manage deviation/ CAPA processes, and collaborate with Production, Regulatory Affairs, Engineering, R&D and QA

Qualifications

• 15+ years of progressive experience in pharmaceutical operations and regulatory interactions.
• Leadership experience in quality assurance, quality control, compliance, or manufacturing operations.
• Experience developing quality system requirements for cGMP compliance and validation.

Responsibilities

• Provide leadership for quality management systems and compliance across production and labs.
• Oversee regulatory authority inspections, audits, and responses; drive corrective actions.
• Lead site Quality initiatives, KPI tracking, and continuous improvement projects.
• Write and revise cGMP documentation and SOPs; ensure adherence to company policies.

Skills

Quality management

Regulatory compliance

Leadership

CAPA

Continuous improvement

Education

Bachelor's in Life Science

Master’s degree desirable

Tools

Documentum

Statistical analysis

Job description

American Regent, Inc. is seeking a high-level Quality leader reporting to the Senior Director of Quality, guiding the quality management system for sterile injectable manufacturing.

You will oversee laboratory operations, regulatory inspections, supplier quality, and external CMOs, ensuring cGMP compliance and robust continual improvement. You will drive KPI-based quality programs, manage deviation/ CAPA processes, and collaborate with Production, Regulatory Affairs, Engineering, R&D and QA