Director of Quality Assurance (QA)

Director of Quality Assurance (QA)

Location: Deer Valley, Phoenix, AZ, 85085 & Chandler, AZ, 85226 (Required to work from both location)

Full Time

Department: Quality Assurance / Quality Systems

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.

Job Summary:

About Client:

Client is a 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, Client is 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 Client s 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 Client 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 company s 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 <797>/<800>, and other applicable regulations.
• Lead and support external audits, including FDA, DEA, and State Board of Pharmacy inspections.
• Collaborate with Manufacturing, QC, Validation, and Regulatory Affairs to maintain compliance throughout the product lifecycle.
• Review and approve SOPs, validation protocols, and quality-related documentation.
• Establish and maintain an effective Quality Management System (QMS) and metrics tracking program.
• Drive initiatives for continuous improvement and risk mitigation across quality processes.
• Provide leadership, training, and mentorship to QA staff to ensure competency and alignment with Client s standards.
• Represent the company in regulatory discussions and serve as a key decision-maker for compliance matters.

Qualifications:

Required:

• Bachelor s degree in chemistry, Microbiology, Pharmacy, or related scientific field.
• Minimum 10+ years of progressive Quality Assurance experience in pharmaceutical manufacturing, with at least 5 years in sterile injectable or aseptic operations.
• In-depth knowledge of FDA, cGMP, USP, and ICH guidelines.
• Proven success managing regulatory inspections and quality systems.
• Demonstrated leadership in building and developing QA teams.
• Strong analytical, problem-solving, and communication skills.

Preferred:

• Master s degree or higher in a scientific or regulatory discipline.
• Experience in 503B outsourcing, sterile fill-finish, or parenteral drug production.
• Familiarity with LIMS, ERP, and electronic QMS platforms.
• Certification in Quality Management (ASQ-CQA, CQM/OE) or Six Sigma.