Head of Quality & Compliance for Sterile Injectables

American Regent, Inc.; Columbus (OH); On-site; USD 170,000 - 210,000; Full time

Job summary

American Regent, Inc. in Columbus, OH, seeks a Senior Director of Quality to lead a multi-disciplinary team responsible for cGMP compliance, laboratory operations, and regulatory inspections across sterile injectables.

This role directs quality systems, CAPA, deviations, change control, and documentation to ensure product safety and regulatory readiness. You will partner with Production, Regulatory Affairs, Engineering, R&D, and QA Compliance to drive continuous improvement, site-wide quality

Qualifications

• Bachelor's in Life Science or equivalent required; Master’s a plus.
• Minimum 15 years progressive pharmaceutical operations experience.
• Minimum 10 years leading quality assurance, control, or manufacturing operations.

Responsibilities

• Provide leadership for quality management systems and compliance; establish performance goals and training plans.
• Oversee deviation, CAPA, change control, and document control processes.
• Lead site-wide quality initiatives and KPI-driven continuous improvement.
• Manage regulatory inspections and supplier/CMO quality activities.
• Ensure cGMP compliance per 21 CFR Parts 210 & 211 and USP requirements.

Skills

Quality leadership

Regulatory compliance

Cross-functional collaboration

CAPA management

Deviation management

Documentation control

Statistical methods

Audits/inspections

Education

Bachelor's in Life Science

Master's degree preferred

Tools

Documentum

Job description

American Regent, Inc. in Columbus, OH, seeks a Senior Director of Quality to lead a multi-disciplinary team responsible for cGMP compliance, laboratory operations, and regulatory inspections across sterile injectables.

This role directs quality systems, CAPA, deviations, change control, and documentation to ensure product safety and regulatory readiness. You will partner with Production, Regulatory Affairs, Engineering, R&D, and QA Compliance to drive continuous improvement, site-wide quality