Quality Affairs Director Sterile Injectables Excellence

American Regent, Inc.; Hilliard (OH); On-site; USD 170,000 - 240,000; Full time

Job summary

American Regent, Inc. seeks a Senior Director of Quality who will lead a multi-disciplinary team responsible for quality systems across sterile injectable manufacturing.

The role interfaces with production, regulatory affairs, engineering, R&D, and suppliers to ensure compliance with cGMP, FDA inspections, and global standards. You will own deviations, CAPA, change control, and document control, drive continuous improvement, coordinate audits, and mentor staff.

Qualifications

• Bachelor’s in Life Science or equivalent; Master’s a plus.
• 15+ years in pharmaceutical operations with regulatory agency interaction.
• 10+ years leading quality assurance, quality control, compliance, or manufacturing operations.
• Expertise in cGMP, regulatory requirements, and quality system development.

Responsibilities

• Provide leadership for quality management systems and compliance; set goals, training plans and provide feedback.
• Oversee deviations, CAPA, change control, Documentum control, and product review processes.
• Lead QA activities to review/approve batch records and support release for shipment.
• Manage regulatory inspections and audits, develop responses and implement improvements.

Skills

Quality management

Regulatory inspections

CAPA & deviation handling

Change control

Documentation control

Team leadership

GxP compliance

Education

Bachelor's in Life Science

Master's degree

Tools

Document management systems

Quality management software

Job description

American Regent, Inc. seeks a Senior Director of Quality who will lead a multi-disciplinary team responsible for quality systems across sterile injectable manufacturing.

The role interfaces with production, regulatory affairs, engineering, R&D, and suppliers to ensure compliance with cGMP, FDA inspections, and global standards. You will own deviations, CAPA, change control, and document control, drive continuous improvement, coordinate audits, and mentor staff.