Job Description

Job Description

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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