Key Responsibilities Develop, implement, and maintain a compliant Quality Management System (QMS) aligned with cGMP, GDP, FDA, and ICH requirements Oversee document control, change management, deviation handling, CAPA, and training programs Conduct and manage internal audits, coordinate customer audits, and support regulatory inspections Ensure compliance across all pharmaceutical storage, handling, and distribution activities, including cold chain logistics for biologics and vaccines Monitor and ensure the integrity of temperature-controlled shipments, including validation of storage and transportation equipment Review and approve investigations, deviations, nonconformances, and customer complaints, including root cause analysis and corrective actions Maintain quality performance metrics and prepare management review reports to monitor system effectiveness Partner with operations, warehouse, and client service teams to ensure adherence to GDP and cold chain requirements Review and approve SOPs, validation protocols, and quality agreements Ensure all associates receive appropriate quality and compliance training Support continuous improvement initiatives to drive operational excellence and regulatory compliance Qualifications Bachelor’s degree in Life Sciences, Quality Management, Engineering, or a related field (advanced degree preferred) 5+ years of quality or compliance experience within pharmaceutical manufacturing Strong knowledge of cGMP, GDP, FDA, and ICH regulations Experience managing quality systems, audits, and regulatory inspections Proven ability to interpret and apply regulatory requirements in a regulated logistics environment Excellent communication, leadership, and problem-solving skills Proficiency with QMS software and standard business tools
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