Assistant Director of QA - Medivant Healthcare : Job Details

Job Title - Assistant Director of QA

Location: Chandler, Arizona & Deer Valley, AZ

Schedule: F/T: Monday through Friday, more details upon interview

Benefits: Health, Dental, Vision, LTD, STD, Accident, Life and 401K with 3% match

Company Overview:

Medivant Healthcare is a leading 503b pharmaceutical outsourcing facility dedicated to providing high-quality, ready-to-administer injectable medications. With state-of-the-art facilities in Chandler and Deer Valley, Arizona, we are committed to maintaining the highest standards of sterility, compliance, and operational excellence. Our mission is to enhance patient care by ensuring a reliable supply of critical medications while adhering to stringent FDA regulations and cGMP requirements.

Position Overview:

The Assistant Director of Quality Assurance will support the overall QA strategy and operations across Medivant's manufacturing sites. This role emphasizes cross-functional quality systems coordination, supplier quality oversight, and continual process improvement. The Assistant Director will work closely with the Director of Quality and lead QA teams in executing day-to-day compliance activities while ensuring adherence to cGMP, FDA, and international regulatory requirements.

Key Responsibilities:

• Oversee and manage Quality Systems including Change Control, CAPA, Deviations, and Document Control across the organization.
• Lead internal audit preparation, execution, and follow-up actions to maintain a state of inspection readiness.
• Coordinate with cross-functional departments to ensure timely resolution of quality events.
• Support regulatory inspections (FDA, DEA, EU, etc.) and contribute to response generation and implementation of corrective actions.
• Ensure batch record review and product release are conducted efficiently and in compliance with regulatory requirements.
• Develop and maintain metrics for QA performance monitoring and continuous improvement.
• Manage supplier quality activities, including qualification, audits, and performance evaluations.
• Provide quality input for new product introductions, technology transfers, and process validations.
• Train and mentor QA staff to build strong technical competencies and ensure adherence to quality processes.
• Collaborate with production and QC teams to identify and mitigate compliance risks.

Qualifications:

• Bachelor's or master's degree in pharmacy, Chemistry, Life Sciences, or related field.
• Minimum of 10+ years of progressive QA experience in a pharmaceutical GMP environment, preferably injectables or sterile manufacturing.
• Strong knowledge of FDA, ICH, and cGMP requirements.
• Excellent communication, problem-solving, and leadership skills.
• Experience in dealing with regulatory authorities and audits.
• Proficient in electronic Quality Management Systems (eQMS) and Microsoft Office tools.