Said Osman

Professional Experience

(Quality Control, Microbiology, QA, QV, Compliance, QMS & Regulatory Leadership)

Executive leader responsible for enterprise-wide Quality strategy and governance across Quality Control, Microbiology, QA, QV, Compliance, Training, Technology Transfer, and Digital/IT Quality Compliance. Member of senior leadership, driving regulatory excellence, operational performance, and a culture of continuous improvement across the organization.

• Held full accountability for end-to-end Quality performance across the business, ensuring alignment with corporate strategy and regulatory frameworks.
• Defined and executed the Quality Vision, Strategy, and Roadmap, embedding best practices to enhance business competitiveness and sustainability.
• Served as Chairman of Site Management Review Meetings and Quality Council, ensuring strong governance, escalation, and decision-making processes.
• Active member of CEO Monthly Governance Meetings, presenting Quality KPIs, risk profiles, and strategic improvement initiatives.
• Contributed to business strategy, annual budgeting, and long-term planning, positioning Quality as a key value driver.

• Led the development, implementation, and continuous enhancement of the Quality Management System (QMS) in compliance with SFDA, EU GMP, and global regulatory standards.
• Directed regulatory compliance of product dossiers, ensuring alignment with post-approval lifecycle requirements.
• Led and governed post-approval changes, ensuring regulatory compliance, risk mitigation, and timely approvals.
• Ensured full inspection readiness through robust internal audits, external audits, and regulatory inspections.
• Drove timely closure of deviations, CAPAs, and audit observations, strengthening compliance and operational discipline.

• Served as Lead Auditor for API, bulk, and finished product manufacturers across Europe, India, and China, ensuring global supplier compliance and qualification.
• Established and led supplier audit and performance management programs, minimizing supply chain risks and ensuring adherence to regulatory expectations.
• Strengthened external partnerships to support reliable, compliant, and high-quality supply continuity.

• Led enterprise-wide Continuous Improvement Programs utilizing DMAIC and Lean Six Sigma methodologies, delivering measurable improvements in quality, efficiency, and cost reduction.
• Chaired Continuous Improvement governance, ensuring structured deployment of improvement initiatives across the site.
• Reduced non-conformances, complaints, and rework through data-driven root cause analysis and preventive actions.
• Implemented performance metrics and benchmarking systems, driving accountability and sustained operational excellence.

• Directed complex Technology Transfer projects from CMOs, TPMs, and R&D, ensuring seamless scale-up, validation, and regulatory compliance.
• Led cross-functional coordination across Manufacturing, Engineering, and Operations to ensure on-time, compliant project delivery.
• Governed System Design Specification (SDS) and feasibility reviews for new product introductions and business opportunities.

• Ensured delivery of products meeting the highest standards of quality, safety, and reliability across the full product lifecycle.
• Established quality and reliability benchmarks aligned with industry standards and customer expectations.
• Proactively managed customer complaints and quality feedback, driving continuous product and process improvements.

• Built and developed high-performing quality teams, enhancing technical capability, compliance awareness, and leadership depth.
• Championed a culture of quality, accountability, and zero-defect mindset across the organization.
• Implemented structured training programs and communication frameworks to ensure consistent understanding of quality standards.

• Promoted a zero-harm safety culture, integrating Environmental, Health & Safety (EHS) into quality systems and operations.
• Applied risk-based thinking across all quality and compliance activities to proactively identify and mitigate risks.

• Established and monitored Quality KPIs and dashboards, ensuring transparency and data-driven decision-making.
• Delivered executive-level reporting on quality performance, risks, and improvement initiatives to senior leadership and governance boards.

• Conducted regular audits across all departments, identifying non-conformities and initiating corrective actions to uphold product quality.
• Achieved 70% quality progress in digital transformation across digital GxP data backup, ERP, EQMS, LMS, AWS, LIMS, and MES.
• Analysed customer feedback and complaint data, pinpointing areas for improvement and leading initiatives to boost satisfaction levels.
• Conducted regular audits across all departments, identifying non-conformities and initiating corrective actions to uphold product quality.
• Implemented improved policies and plans to enhance operational processes.
• Promoted a culture of quality awareness throughout the organisation, fostering a proactive approach to quality management and improvement.
• Reviewed and updated quality policies and procedures, reflecting changes in regulations and business needs to maintain relevance and effectiveness.
• Established key performance indicators KPIs for quality objectives, monitoring progress and adjusting strategies to achieve targets.
• Led staff hiring, training and performance goals.
• Implemented continuous improvement programmes, utilising Lean and Six Sigma methodologies to drive efficiency and reduce waste.
• Organised and chaired quality review meetings, presenting findings and recommendations to senior management for strategic decision-making.
• Enforced standards of work and reporting deadlines.
• Monitored industry trends and technological advancements, adopting innovative practices to enhance quality management processes.
• Liaised with suppliers to establish quality requirements for raw materials, securing consistency and compliance with industry standards.
• Planned project labour, expenses and timeframes to continuously achieve output and quality targets.
• Minimised costs by adjusting processes, managing budgets and controlling expenses.
• Led successful global supplier qualification audits (EU, India, China) with sustained regulatory compliance
• Delivered Lean Six Sigma transformation, achieving significant reduction in deviations and cost of poor quality
• Successfully managed post-approval regulatory changes with zero compliance gaps
• Maintained inspection readiness, achieving successful regulatory inspections with minimal observations

• Managing all QC activities and technology transfer projects
• Managing external audit from multinational companies (Servier, Abbott, Apotex, Novartis, lundbeck..etc.) and regulatory bodies (GCC and EMEA)
• Managing new project life cycle (URS, DQ, IQ, OQ, PQ) as instruments, LIMS, and participate in ERP and eQMS
• A review of all OOS investigation, change control, deviation, incidents, failure etc.
• A review of all significant deviations or non-conformances, their related investigations, and the effectiveness of resultant corrective and preventative actions taken
• Approval of all created and executed TSD and ROA
• A review of Marketing Authorisation variations submitted/granted/refused, including those for third country
• Approval of the results of the stability monitoring programme and any adverse trends
• A review of all quality-related returns, complaints and recalls and the investigations performed at the time
• For new marketing authorisations and variations to marketing authorisations, a review of post-marketing commitments
• AJA Pharma, Hail-KSA
• Applied Quality Assurance (QA) methodologies to measure output quality.
• Led quality control department, overseeing team performance and compliance with industry standards.
• Maintained up-to-date knowledge of regulatory changes impacting quality assurance practices.
• Monitored regulatory compliance, staying abreast of changes in standards and legislation.
• Collaborated with cross-functional teams to develop quality standards for new product launches.
• Assessed completed batch records, evaluating successes and highlighting areas requiring quality improvements.
• Supported timely, quality product release through diligent production analysis and evaluation.
• Oversaw calibration and maintenance of testing equipment, guaranteeing accurate measurement.
• Established robust inspection criteria for incoming goods, elevating overall product quality.
• Conducted regular training sessions for staff on quality control techniques and company policies.
• Established key performance indicators for quality objectives, tracking progress towards goals.
• Coordinated and participated in internal and external quality management system audits to guarantee product and quality specifications.
• Monitored compliance with regulatory requirements to mitigate risks and uphold company reputation.
• Performed thorough quality investigations, identifying key development strategies and supporting idea implementation.
• Reduced workplace incidents by implementing occupational health and safety requirements.
• Analysed production data to identify trends, making recommendations for continuous improvement.
• Introduced lean manufacturing principles to the quality control process, reducing waste.

• A review of critical in-process controls and finished product results
• A review of all batches that failed to meet established specification(s) and their investigation
• A review of all significant deviations or non-conformances, their related investigations, and the effectiveness of resultant corrective and preventative actions taken
• A review of all changes carried out to the processes or analytical methods
• A review of Marketing Authorisation variations submitted/granted/refused, including those for third country (export only) dossiers
• A review of the results of the stability monitoring programme and any adverse trends
• A review of all quality-related returns, complaints and recalls and the investigations performed at the time
• For new marketing authorisations and variations to marketing authorisations, a review of post-marketing commitments
• Arab Company for Medicinal Plants and pharmaceutical products

• Validation of process and equipment and BE studies
• Developed comprehensive risk management plans for each project phase, mitigating potential obstacles to successful outcomes.
• Led day-to-day R&D activities and related project planning and resource allocation.
• Collaborated with cross-functional teams to deliver projects on time and under budget.
• Negotiated with external suppliers to secure high-quality materials for research projects, achieving a 15% reduction in costs.
• Spoke at conferences and led seminars detailing research activities and results.
• Coordinated with marketing and sales teams to align R and D objectives with market needs, maximising product impact.
• Approving the agreements and protocols
• Performing the comparative dissolution profiles for Generic and Brand products
• Calculating the Difference (f1) and Similarity Factors(f2)
• Preparing and analyzing working standards for BE studies
• Auditing CROs centers in Jordan as PRU center and PharmaquistJo
• Monitoring and following up BE studies in Jordian CROs
• Reviewing the final reports of BE studies
• Egyptian Group for Pharmaceutical Industries

• Methodology; Method development and validation
• Stability indicating methods using HPLC and HPTLC methods
• Charge Transfer Complex formation methods
• Oxidation and potentiometry methods
• Coordinating with EIPICO registration department in: Performing and reporting stability studies for registration file
• Preparing raw material specifications and updating them
• BE studies
• Reviewing local and international registration files
• Using the last version of the following software: Winnonline
• Used for calculation of pharmacokinetic parameters
• Using SLIMstat software for calculation of shelf life of the product
• Using Minitab software and SPSS for calculation of Power, Sample size, F-test, t-test and ANOVA
• Egyptian International for Pharmaceutical Industries Company

• Auditing Laboratory Quality Management System
• Executing training Program
• Investigating OOS results
• Quality Manager in Laboratory Accreditation Program
• Preparing Analysis Specification
• Executing Calibration Program
• Auditing cGMP system
• Collaborated with team members to achieve target results.
• Managed complaints with calm, clear communication and problem-solving.
• Trained and mentored employees to maximise team performance.
• Developed excellent working knowledge of industry trends and improvements in processes.

• Analyse raw materials across HPLC, GC, and IR spectrophotometer workflows.
• Inspected output samples, checking for faults and quality using appropriate methods.
• Inspected and tested products, parts and materials for conformity with specifications and standards.
• Conducted thorough quality control analyses on incoming raw materials to maintain product standards.
• Performed analytical testing accurately and timely consistent with cGMP requirements.
• Lead structured testing using UV spectrophotometer, TLC densitometry, and atomic absorbance.
• Apply GLP, ISO, and cGMP quality standards in Q.C. laboratories.