Harba Solutions Inc.
Direct message the job poster from Harba Solutions Inc.
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
#J-18808-Ljbffr
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
#J-18808-Ljbffr