Distribution Center Quality Assurance Manager - Pharmaceutical & Vet Care Product Regulatory

Position: Distribution Center Quality Assurance Manager - Pharmaceutical & Vet Care Product Regulatory Co[...]
* Lead and manage a team of Quality Assurance professionals, providing coaching, performance feedback, and development opportunities to ensure high engagement and effectiveness.
* Oversee the implementation and maintenance of quality systems and processes to ensure compliance with applicable regulatory requirements across In-Clinic Operations.
* Coordinate and conduct internal audits, risk assessments, and gap analyses to proactively identify areas for improvement and ensure operational readiness for external inspections.
* Serve as the primary point of contact for regulatory agencies on defined matters, facilitating communication, and ensuring timely resolution of compliance issues.
* Collaborate cross-functionally with In-Clinic Operations, Legal, and Regulatory teams to prepare and submit documentation packages for external audits, inspections, and regulatory findings.
* Monitor and analyze quality metrics and trends to drive continuous improvement initiatives.
* Develop and maintain SOPs, training materials, and documentation to support consistent quality practices across all In-Clinic locations.
* Support change management efforts related to quality and compliance, ensuring alignment with organizational goals and regulatory expectations.
* Bachelor’s degree in a relevant field such as Quality Management or related discipline preferred; equivalent combination of education and experience considered.
* 5+ years of experience in quality assurance or regulatory compliance, preferably within a pharmaceutical distribution environment.
* 2+ years of people management experience, including leading teams, coaching, and performance development.
* Experience with regulatory audits, documentation control, and risk management.
* Strong knowledge of quality systems, regulatory standards, and compliance frameworks.
* Excellent leadership and team development skills, with the ability to motivate and guide a distributed team.
* Proficient in audit planning and execution, root cause analysis, and corrective/preventive action (CAPA) processes.
* Effective communication and collaboration skills across cross-functional teams with external regulatory bodies.
* High attention to detail, analytical thinking, and problem-solving abilities.
* Comfortable with data analysis tools, quality management software, and Microsoft Office Suite.
* Reports directly to VP, Quality & Regulatory Operations*.
** This is a hybrid role, with less than 50% in-office presence required; occasional travel to In-Clinic sites may be necessary for audits or team engagement.
* Must be able to work in a standard office environment and occasional distribution center/pharmacy operations settings, which may involve standing or walking for extended periods.
* Ability to manage multiple priorities in a fast-paced, dynamic environment with minimal supervision.
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