Faiz Khan
Global Clinical Quality Assurance (Cqa) @Olympus Corporation
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WORK HISTORY
Global Clinical Quality Assurance (Cqa) @Olympus Corporation
Munich, DE
Lead or assist in Quality processes, audit, and inspection readiness to ensure compliance with Olympus policies, regulatory requirements, and global guidelines.Identify non-conformances, provide recommendations, and drive quality improvements using a risk-based methodology while maintaining regulatory compliance.Develop and maintain key Clinical Quality metrics for process improvement initiatives and presentations to Study Management Teams and Senior Leadership.Lead the development and delivery of clinical quality and compliance training to internal functional groups.Ensure study teams follow SOPs and compliance requirements throughout clinical studies.Assist in developing risk-based GCP audit strategies across clinical programs and studies.Plan, develop, and manage audits of clinical vendors, clinical sites, and internal processes, including follow-up activities (e.g, reports, corrective actions).Perform clinical study documentation reviews for data integrity and compliance, including Quality Control checks of the eTMF for inspection readiness.Ensure appropriate oversight of the Computer Software Validation program.Oversee Vendor Qualification and Management programs to ensure compliance and efficiency.Conduct audits, risk assessments, and inspections of clinical study vendors.Utilize root cause analysis techniques to work with vendors in improving processes and eliminating compliance issues.Collaborate with the Olympus Quality organization to support audit/inspection readiness activities and drive process improvements.
EDUCATION
Rajiv Gandhi Prodyogiki Vishwavidyalaya
Diploma
Rajiv Gandhi Prodyogiki Vishwavidyalaya
Pharmacist
ABOUT FAIZ KHAN
Pharmacist & Global Quality Leader with 15+ years of experience in multinational pharmaceutical and medical device companies. I specialize in GCP, GMP, GLP and ISO 14155 compliance, transforming clinical audits into strategic insights and driving regulatory success across global drug development programs. Clinical QA Expertise (GCP/GCLP) Led Phase clinical trials (small & large molecules) with cross-functional teams across global regions. Ensured inspection readiness for FDA, EMA, MHRA, NPRA through proactive risk mitigation and robust quality systems. Conducted 60+ audits, implemented risk-based QA strategies, and led eQMS rollouts (Veeva, TrackWise). Skilled in CAPA management, Microsoft Project, and matrix leadership. GMP/GLP QA Experience Delivered 30+ complex QA projects including product transfers, process validation, and QC across MEA, Turkey-CIS, APAC, and Europe. Supported new product launches, lifecycle management, and quality risk management initiatives. QA Leadership in Merger Acquisitions Transitions Spearheaded QA transitions during mergers and acquisitions, integrating GCP/GVP QMS, SOP harmonization, and quality agreements.
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