Manager of Drug Quality, Veterinary Compounding Pharmacy

Covestro•Phoenix, AZ

9d•Onsite

About The Position

The Manager of Drug Quality, Veterinary Compounding Pharmacy is responsible for leading quality and compliance programs within 503A compounding operations, with direct oversight of laboratory testing activities. This role partners closely with Quality and Regulatory Affairs (QRA) leadership to ensure adherence to regulatory requirements, strengthen quality systems, and drive consistent, compliant operations. This leader plays a critical role in ensuring product quality and patient safety through effective quality oversight, timely issue resolution, and continuous improvement initiatives. The position also oversees laboratory testing operations, ensuring accurate, timely, and compliant analytical results that support product release and operational excellence within the compounding pharmacy. This position will be onsite in our Compounding Lab at 2401 W. Grandview Rd, Phoenix, AZ.

Requirements

Minimum of 5+ years of experience in a quality assurance role within a compounding pharmacy or regulated pharmaceutical environment.
Working knowledge of 503A regulations, including USP, FDA, and state board of pharmacy requirements.
Experience supporting quality systems, audits, and investigations.
Strong organizational, analytical, and problem-solving skills.
Effective communication and collaboration skills.
Bachelor’s degree in pharmacy, Chemistry, or related field.

Responsibilities

Lead and manage laboratory testing operations, ensuring all analytical activities (e.g., potency, sterility, endotoxin, and other required testing) are performed accurately, efficiently, and in compliance with regulatory and compendial standards.
Establish and maintain test methods, specifications, and procedures, ensuring appropriate validation and consistent execution.
Review and approve laboratory data and test results to support product disposition and release decisions.
Lead investigations for out-of-specification (OOS), out-of-trend (OOT), and atypical results, ensuring robust root cause analysis and effective corrective actions.
Oversee laboratory-related quality systems, including equipment qualification, calibration, maintenance, and environmental monitoring programs.
Provide leadership and direction to lab personnel, including prioritization of testing, troubleshooting, and adherence to analytical and aseptic best practices.
Execute and continuously improve quality and compliance programs within 503A compounding operations.
Ensure adherence to USP, FDA, and state board of pharmacy requirements; proactively identify and escalate compliance risks.
Maintain and enhance quality management systems, including SOPs, deviations, CAPAs, change controls, and investigations.
Review compounding records and support product disposition decisions in alignment with established procedures.
Track, trend, and report quality metrics to drive data-informed decisions and continuous improvement.
Partner cross-functionally with compounding operations to align production and testing activities, including sample management, turnaround times, and issue resolution.
Support internal and external audits, inspections, and vendor qualification activities, ensuring inspection readiness at all times.
Drive process improvements to enhance product quality, operational efficiency, and regulatory compliance.
Provide day-to-day leadership, coaching, and development for team members, fostering a culture of quality, accountability, and continuous improvement.
Support onboarding, training, and performance management to build a high-performing team.
Perform other duties as assigned.