Director of Quality Assurance (Chandler)

Director of Quality Assurance (QA)

Location : Chandler, AZ and Deer Valley, AZ (you will only have to go to deer valley location until the summer of 2026)

Department : Quality Assurance / Quality Systems

Reports to : Chief Operating Officer (COO) or VP of Quality

U.S.-based pharmaceutical manufacturer specializing in sterile injectable generic medications for hospitals and healthcare providers nationwide. Operating from FDA-registered facilities in Chandler and Deer Valley, Arizona. We are dedicated to producing safe, high-quality, and affordable pharmaceuticals that meet the highest standards of cGMP and FDA compliance.

Position Summary

The Director of Quality Assurance provides strategic leadership and direction for all aspects of our quality systems, compliance, and regulatory operations. This role ensures adherence to FDA, DEA, cGMP, and USP regulations while fostering a strong culture of quality across the organization.

The Director will oversee QA teams at both production sites, manage regulatory inspections, drive continuous improvement initiatives, and ensure that all products meet the company's commitment to excellence and patient safety. Experience in sterile injectable manufacturing or aseptic operations is required.

Key Responsibilities

• Lead and manage the Quality Assurance department, including quality systems, document control, and compliance functions.
• Serve as the companys primary quality authority for all cGMP-related matters, including product release and regulatory inspections.
• Oversee batch review, deviation investigations, CAPA programs, and change controls.
• Ensure adherence to 21 CFR Parts 210 / 211, USP

, and other applicable regulations.

Qualifications

Required :

Preferred :

Work Environment

Onsite role across both Chandler and Deer Valley facilities. Includes office and cleanroom exposure as part of quality oversight. Standard weekday schedule, with flexibility during audits or production releases.

Benefits