Omar A.
Fractional Chief Technical and Quality Officer Advisory @Kaly Group
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WORK HISTORY
Fractional Chief Technical and Quality Officer Advisory @Kaly Group
I am leading the scale-up of innovative processes that use green chemistry and physical engineering to to achieve operational excellence, overseeing biorefinery commissioning and the integration of advanced technologies to streamline manufacturing workflows and enhance productivity. Directing strategic planning and execution for technology transfer, optimising quality frameworks and ensuring regulatory compliance during manufacturing transitions, while collaborating with third-party vendors to drive efficiency. I implement state-of-the-art automated quality control systems to improve inspection readiness and foster innovation. I spearhead global compliance strategies aligned with international regulatory standards, and oversee vendor selection, onboarding, and quality audits. Providing strategic guidance to cross-functional teams, I ensure robust quality assurance and regulatory alignment across high-impact projects. Additionally, I apply Quality by Design (QbD) principles through CQA assessment and process control strategies in line with QTPP expectations, and lead process validation, scale-up activities, and continuous process verification to drive product quality and process excellence.
EDUCATION
University of the West of Scotland
Master of Business Administration - MBA, Business Administration, Management and Operations
The University of Bonn
Certificate , Course on "GxP - Good Practice" Quality Guidelines and Regulations in Biomedicine
University of the West of Scotland
Postgraduate Certificate in Academic Practice (PgCAP) Master Level Certificate
Keele University
Doctor of Philosophy - PhD, Pharmacy
Ashorne Hill - The Home of Ashorne Advantage
Certificate in management , Business Administration and Management, General
Summer School in Pharmaceutical Analysis (SSPA 2016)
Certificate, Advanced Analytical Methodologies for Biotechnological and Biological medicinal products
ABOUT OMAR A.
I am a global pharmaceutical executive with 24+ years of leadership experience across Manufacturing Science & Technology (MS & T), Technical Services (TSMS), Quality, and Regulatory Compliance. I help pharma and biotech organizations turn complex manufacturing and quality operations into efficient, compliant, and high-performing systems by integrating GMP frameworks with enterprise systems, governance, and KPI/KQI intelligence to optimize the end-to-end product lifecycle. My expertise spans small molecule API manufacturing, external manufacturing oversight, sterile and advanced therapies, and complex regulatory environments. I have successfully led global technology transfers, process validation initiatives, and implemented robust QbD strategies across international networks. I’ve overseen regulatory submissions (Module 3 CMC), engineering, vendor management, and global maintenance programs, connecting day-to-day operations with strategic business goals. Throughout my career, I’ve partnered extensively with CDMOs, CMOs, and CROs, acting as Person-in-Plant, driving supplier performance, risk management, and continuous improvement. My leadership during inspections (MHRA, EMA, FDA) and a 100% success rate in regulatory submissions (MAA, NDA, BLA, ANDA) reflect a strong commitment to technical excellence and compliance. I am passionate about fostering high-performing, cross-functional teams, driving operational efficiency, and delivering life-changing medicines to patients worldwide. I thrive on collaboration, innovation, and aligning technical strategies with business objectives across the UK, EU, US, NA, and GCC markets.#APIManufacturing #ExternalManufacturing #TSMSLeadership #TechTransfer #RegulatoryCompliance #GMPExcellence #PharmaQuality #CMC
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