Global Quality & Compliance Director

American Regent, Inc.; Shirley (NY); On-site; USD 180,000 - 240,000; Full time

Job summary

American Regent, Inc. seeks a Sr. Director of Quality reporting to the VP of Quality Affairs.

This role leads a multidisciplinary team across production to ensure quality management systems, regulatory compliance, and continuous improvement for sterile injectables. Responsibilities include oversight of laboratory operations, regulatory inspections (FDA), supplier and CMO quality, and strategic quality initiatives.

Qualifications

• Bachelor's in Life Science or equivalent required; Master’s Degree a plus.
• Minimum 15 years progressive experience in pharmaceutical operations and regulatory interactions.
• Minimum 10 years leading functional quality assurance, quality control, compliance, or manufacturing operations.
• Expertise in cGMP, pharmaceutical drug production, and laboratory facilities.
• Strong written and verbal communication skills; proven leadership能力.

Responsibilities

• Provide leadership and direction for quality management systems and compliance across the site.
• Maintain site-wide cGMP compliance per 21 CFR Parts 210/211, USP, and related guidelines.
• Oversee regulatory authority inspections, audits, and responses; drive improvements.
• Drive continuous quality improvement and KPI programs using statistical methods.
• Coordinate with internal/external customers and regulatory agencies on quality issues.

Skills

Quality leadership

Regulatory knowledge

Communication skills

People and program management

Statistical methods

Education

Bachelor's in Life Science or equivalent

Master’s Degree preferred

Job description

American Regent, Inc. seeks a Sr. Director of Quality reporting to the VP of Quality Affairs.

This role leads a multidisciplinary team across production to ensure quality management systems, regulatory compliance, and continuous improvement for sterile injectables. Responsibilities include oversight of laboratory operations, regulatory inspections (FDA), supplier and CMO quality, and strategic quality initiatives.