Omar A.

Fractional CTO | Scientific & Technical Advisor @ Strategic Remedies Ltd

About

I build enterprise systems that integrate GMP and regulatory frameworks with governance and KPI/KQI intelligence to optimise the end-to-end product lifecycle. I am a global pharmaceutical executive with over 24 years’ leadership experience across Manufacturing Science & Technology (MS&T), Technical Services (TSMS), Quality, and Regulatory Compliance. I aim to create a multidisciplinary research ecosystem that addresses global and regional healthcare challenges. My expertise spans small molecule API manufacturing, external manufacturing oversight, sterile/advanced therapies, and highly complex regulatory environments. I have successfully led global technology transfer and process validation initiatives for API and drug product manufacturing, optimised critical process parameters, and implemented robust QbD strategies across diverse international networks. Throughout my career, I have partnered extensively with CDMOs, CMOs, and CROs acting as Person-in-Plant and driving supplier performance, risk management, and continuous improvement. My leadership during regulatory 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 driving operational efficiency, fostering a culture of accountability, and delivering life-changing medicines to patients worldwide. I thrive on collaboration, innovation, and developing high-performing, cross-functional teams to meet evolving business and regulatory challenges. As a strategic leader, I also bring deep experience in people management and stakeholder engagement providing clear direction, mentoring diverse teams, and aligning technical strategies with business objectives across the UK, EU, US, NA and GCC markets. #APIManufacturing #ExternalManufacturing #TSMSLeadership #TechTransfer #RegulatoryCompliance #GMPExcellence #PharmaQuality#CMC

Country

United Kingdom

City

Glasgow

Industry

Pharmaceuticals

Skill

Kerry Solutions for Biopharma, International Regulations, Project Management, Clinical Trials, Presentations, Strategy, Consulting, Clinical Development, Analytical Skills, Good Manufacturing Practice (GMP), People Management, Regulatory Approvals, Internal Audits, Performance Metrics, Regulatory Reporting, Medical Devices, Management, Regulatory Affairs, Quality Assurance, Design Control

Experience

Fractional CTO | Scientific & Technical Advisor

Strategic Remedies Ltd

2023-2 - Present · 3 yrs 8 mos

Supporting early-stage and growth-phase companies across scientific, technical, and operational domains. Areas of focus include R&D strategy, product development, quality systems (QMS), team building, and preparing companies for scale. ANDA, NDA, BLA, IND, CTA, MAA, and eCTD, with integrated CMC and GMP strategies to ensure quality is built into the process "Quality by Design (QbD), risk management (ICH Q9)" not just tested at the end. I’ve led inspection readiness initiatives, hosted global regulatory inspections (FDA, EMA, MHRA), product certification (Annex 16), and implemented sustainable MS&T strategies for advanced therapies, sterile manufacturing, and complex biologics. Currently transitioning into a full-time senior leadership role to contribute long-term impact and execution within a growing organisation.

Higher Education Consultant

London South Bank University

2022-1 - Present · 4 yrs 9 mos

I lead and deliver engaging, high-impact lectures in Pharmaceutical Sciences and Drug Discovery, while driving the development and continuous enhancement of forward-thinking academic programs. I design and implement robust assessment strategies to ensure academic excellence, and play a strategic role in student recruitment, spearheading initiatives that align with institutional goals and amplify course visibility through targeted marketing efforts.

Fractional Chief Technical and Quality Officer | Advisory

Kaly Group

2024-7 - Present · 2 yrs 3 mos

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.