Sabah brings over 16 years of specialized expertise in pharmaceutical quality assurance, compliance, and pharmacovigilance to CLINIGMA^®. As Chief Quality Assurance Officer, she ensures that all operations meet the highest international standards while maintaining rigorous oversight of quality systems and regulatory compliance.

Quality Management Leadership

• Global Quality Head experience with comprehensive oversight of organizational compliance activities
• ISO 9001 and ISO 27001 Lead Auditor certifications with extensive internal and external audit management
• Expert in CAPA Management, Change Management, and GxP validation across multiple organizational levels
• Proven track record managing client and supplier audits at organizational level

Pharmacovigilance and Drug Safety Excellence

• Over 10 years at global CRO with progressive responsibility in drug safety operations
• Expert in case registry, triage, and processing of adverse event reports across all report types
• Comprehensive experience with spontaneous, solicited, clinical trial, literature, legal cases, pregnancy, overdose, and medication error reports
• Advanced skills in auto-coding of adverse events using MedDRA tools and labeling assessment

Regulatory Compliance Expertise

• Specialized experience in regulatory compliance metrics monitoring and business partner late case investigations
• Expert in legacy data migration projects and validation of GxP systems
• Proven ability to coordinate audit and inspection readiness activities
• Comprehensive understanding of global regulatory requirements and compliance frameworks

Operations and Process Management

• Extensive experience leading operations teams including case registry, triage, processing, medical review, and quality review functions
• Expert in narrative writing and quality review of case reports with focus on accuracy and regulatory compliance
• Proven ability to establish project protocols, scope of work, and maintain comprehensive project materials
• Advanced skills in database management and workflow optimization

Quality Systems and Continuous Improvement

• Expert in maintaining process-level compliance across training, quality management, and organizational activities
• Advanced knowledge of deviation memo preparation and administrative process management
• Extensive experience in quality parameter monitoring and improvement initiatives

Sabah's comprehensive background in pharmaceutical quality assurance, combined with her deep regulatory knowledge and proven leadership capabilities, ensures that CLINIGMA^®'s quality management systems exceed industry standards. Her extensive experience across global pharmaceutical operations provides clients with confidence that their projects will meet the most stringent quality and compliance requirements.

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