Radwa Salem
Summary
Quality and Compliance Subject Matter Expert passionate about fostering quality and committed to continual improvement. Successfully leveraging proactive and sustainable quality of GxP activities at local and regional levels for providing high-quality products to save or change patient lives.
Overview
15
15
years of professional experience
9
9
Certifications
3
3
Languages
Work History
Regional Quality Assurance Manager
ACINO
Cairo
08.2019 - Current
- Established, maintained, and continually improved local quality management system for GxP related activities for imported and locally manufactured products across META including new legal entities and/or local Marketing Authorization Holder (MAH) in Egypt, UAE, Turkey, and KSA
- Put in place annual quality plan and updated Site Master File (SMF) for META GxP activities. Ensured timely execution of quality plan
- Performed gap assessment and developed regional and local GxP related processes (e.g., PV, medical, regulatory, marketing, HR, compliance, supply chain) in META countries. Contributed to development, and review of global GxP SOPs
- Reviewed and checked batch documentation for correctness and completeness in accordance with approved registered specifications and local regulations
- Ensured resolution of issues (e.g., temperature excursions, damage, missing packs) before product/batch release to markets via distributors in META countries
- Conducted 10+ training sessions on SOPs for cross-functional stakeholders (e.g., META leadership, Country Managers/Cluster Heads, Regulatory, PV, Supply Chain, Medical, IT, Compliance, etc.)
- Set quality mindset by conducting annual quality awareness training for all META employees of different countries/functions of region, resulting in improved quality and compliance of GxP related activities
- Achieved distinguished quality and compliance in oversight of 30 high/medium-risk GxP third parties/vendors across META including due diligence, evaluation, quality risk assessment, and mitigation, qualification, auditing, quality agreements, and monitoring ongoing quality performance
- Executed 15+ GDP audits in accordance with external quality audit plan to identify areas of improvement and enforce compliance across META with quality manual, quality agreements, quality standards, relevant GxP regulatory requirements, SOPs and with all aspects of handling and distribution of products
- Participated in 5+ external GMP audits as Co-auditor in Egypt, UAE and KSA
- Preparation, execution, and follow-up of internal and external risk-based audits and self-inspections in META countries
- Conducted/supported QA investigations, root cause analysis, impact assessments, and ensured appropriate and timely implementation of effective CAPAs for audit/inspection findings or noncompliance/quality issues in META (e.g., deviations, complaints, recalls, counterfeits / product tampering and out of specification /stability failures). Escalated issues to Senior Management and Corporate QA and initiated any required market action
- Supported local regulatory Inspections for GxP activities to ensure regulatory commitments are met and to maintain site license
- Managed GxP change requests from initiation till implementation and closure
- Participated in review of corporate TQA template and developed regional/local TQA templates for GxP related activities in META countries
- Assured high quality and consistent compliance with no critical internal audit findings of GxP related activities in META countries according to applicable international guidelines, GxP regulations, policies, and procedures
- Drove continuous improvement by evaluating Annual Management Review Report and monitoring monthly KPIs and metrics of local QMS performance for repeated issues and quality trends across META
- Led Quality Management Review and gave professional presentations to META QA Director and Corporate QA team by communicating optimally milestones, projects’ progress, and discussing challenges and improvements
- Led regional/local QA projects/initiatives in META countries to shape organization
- Maintained quality standards across current and planned business acquisitions
- Supported localization, legal entity, new product launches, and MAT in Egypt, UAE and KSA for GxP related activities in collaboration with Project Managers, BD, Regulatory, Supply Chain, Legal, Marketing, and Commercial teams
- Played key role in acquisition and integration of new products in Egypt, UAE, KSA and other META countries before MAT approvals
- Leveraged META region for growth, identify opportunities for harmonization and diversification
- Restructured and harmonized 20+ local/regional GxP processes with global SOPs
- Developed for META GxP training management process and training matrix by gathering, and modeling data from various sources to assess training needs
- Analyzed effectiveness of training at all levels and recommended updates
- Rolled-out across META on-boarding, and annual continuous training including job-specific internal and external training curricula and programs
- Foster quality culture and contributed to execution of Compliance Day for META
- Continued strong communication and cross-functional collaboration with Country, Regional, and Global QA, Qualified Persons, Site QA Heads, GxP functions, and META Stakeholders as One team
- Achieved set up, migration and implementation of electronic systems in META e.g., SAP, Electronic Learning Management System (e-LMS), Electronic Document Management System (eDMS), and TrackWise system for change controls, complaints, deviations, company records, internal/external audits, and CAPAs
- Conducted e-LMS training to all META employees in all countries of region
- Supported implementation of SAP / local warehouse management system software applications to enable centralized management of tasks in countries
- Created and optimized records management strategies to coordinate and protect data
Regional / Local Affiliate Process and Training Manager
ROCHE, Middle East Clinical Operations Hub
Cairo
05.2015 - 06.2018
- Worked with top Principal investigators in various therapeutic areas. Oversaw conduct for 40+ clinical studies in 70+ top clinical research entities. Collaborated with line managers and functions to develop and deliver new training modules to ensure staff was prepared and curriculum aligned with global training grid and regional/local needs. Managed risks and issues affecting clinical studies. Developed clinical trial quality control and compliance plan, monitored GCP compliance via compliance visits, metrics, and evaluation of non-compliance areas and ensured implementation of effective CAPA in collaboration with stakeholders. Led audit/inspection readiness to support GCP, PV, RA, and MA staff. Conducted 40+ training sessions on drug development, clinical research, GCP, global and local processes, initiatives, systems, and tools for cross- functional teams and GCP/GVP vendors. Trained 30+ investigators and site staff on GCP, informed consent process and study protocol. Beyond Award in EEMEA for excellence in business partnering and innovation and Certificate of Recognition for outstanding contributions in developing “BULLET” integrated cross- functional workplace tool.
- Optimized quality, compliance, and function efficiency by continuously improving regional and local clinical operations despite unclear guidelines and regulations
- Set clinical research standards for trial conduct in four Middle East countries after 4 years of clinical trial hold by assessing local regulations, ethics committee requirements, country- specific SOPs/business processes, sites’ qualification
- Achieved high-quality standards and compliance of drugs saving patient lives by advising cross-functional stakeholders across countries on process, training, systems, and clinical trials issues, and ensuring enforcement of international, local regulations, U.S FDA, EU directives, ICH, and GCP as Subject Matter Expert
- Improved speed of registration of new drugs and new indications to save or change patient lives by ensured high- quality data from various clinical studies conducted at affiliate and regional levels
- Managed projects and achieved milestones within required timelines for quality, compliance, standards, processes, and training despite obstacles
- Attracted and maintained clinical trials to region by detecting risks, risk trends, and mitigation at countries, studies, and sites levels
- Deployed improvement of clinical operations, study team performance, and sites, enabled follow-up on completion of solutions to gaps, and tracked progress of actions by introducing audit and inspection readiness program and conducted thorough risk-based process, system, and training reviews
- Zero audit findings in corporate, safety, and investigational medicinal product (IMP) audits, 2015
- Established cross-company compliance standards, business continuity, and local/affiliate, project that was replicated in other countries in region
- Developed country-specific local SOPs, and business processes essential to launching Hub activities
- Achieved 96% satisfaction per survey results as global GCP trainer in 12 WebEx training sessions for clinical operations across EEMEA countries as part of global e-learning program
Local Quality Responsible-Egypt and Gulf Countries
ROCHE
Cairo
06.2013 - 12.2017
- Reviewed QMS performance status with leadership team and local medical compliance office. Oversaw quality and compliance and ensured audit and inspection readiness for GxP activities by conducting investigations, root cause analysis, impact assessment, implementing effective CAPAs for deviations, findings, assessments, risks, quality/non-compliance issues, and ensuring maintenance and improvement of activities. Awarded “Applause” for local and regional achievements and contributions.
- Achieved distinguished quality and compliance in managing and overseeing 10+ high-risk service providers
- TQA management with service providers and distributors e.g Warehouses
- Conducted site audits to ensure vendors' processes are compliant with TQA
- Instilled quality mindset to establish, maintain and improve QMS in GxP activities in Egypt and five other Gulf countries including setting company strategy and governance, operational effectiveness, process and procedures, handbook, GxP documents, quality plan, training and compliance risk management framework
- Maintained green affiliate(s) passport for 3 years to ensure continuation of increase in GxP activities
- Influenced shape of current and new regulations by engaging partners and stakeholders to anticipate and evaluate impact and prepare for regulatory changes, business risks, audit, and inspection trends and results
- Streamlined local, and regional GxP SOPs, and processes
- Assured high quality and consistent compliance with no audit findings of GxP activities according to international guidelines, local regulations, laws, policies, and procedures by overseeing qualification, quality risk assessment, monitoring, and reporting service providers performance via oversight plans, and monthly KPIs, overseeing product complaint handling process, coordinating medical information, local PV, and regulatory activities, and overseeing GxP processes via metrics, and assessing and aligning controlled documents with global standards
- Drove continuous improvement by producing quality reports for use in making business decisions, maintaining green compliance metrics, periodic quality management reviews of performance, audits, and inspection findings, self- identified deviations, common root causes, CAPAs, training gaps, trend analyses, and quality signals across various sites, studies, programs, compounds, and countries and proposing new controls to update current processes and enhance team efficiency/effectiveness
Compliance and Training Officer / QA Manager
ROCHE
Cairo
11.2012 - 05.2015
- Monitored quality processes and procedures. Organized workshops, presentations, and local awareness sessions for medical department staff including clinical operations, PV, regulatory, and medical on ICH GCP, global/local SOPs, and local laws/requirements. Oversaw quality and compliance for 20+ clinical studies and programs at various stages.
Senior Clinical Research Associate / Clinical Research Associate
ROCHE
Cairo
08.2009 - 11.2012
- Led first local and global interventional multi-center clinical trials for Actemra and Avastin with over 100 patients in more than 10 top research centers with 10+ investigators
- Awarded for Egypt and EEMEA first early Phase III Global Interventional Multi-Center Clinical Trial (BO21004/CLL11) Completion
- Enhanced registration of Actemra and Avastin in local market for Egyptian patients because of high quality data generated from clinical studies
- Managed fast worldwide patient recruitment, informed consent process, and data entry achieving global study objectives across various countries in accordance with study timelines and budgets.
Patient Educator
SANOFI
Cairo
04.2008 - 08.2009
- Educated patients with Diabetes and Cardiovascular Diseases through sessions and partnerships with physicians, healthcare professionals and community organizations on importance of health education and specific disease prevention and treatment strategies to help communities improve health and well-being.
Education
Post-Graduate Diploma - Clinical Pharmacy
Ain Shams University, College of Pharmacy
Cairo, EgyptBachelor of Science (BS) - Pharmaceutical Sciences
Ain Shams University, College of Pharmacy
Cairo, EgyptSkills
Critical Thinkingundefined
Area of Expertise
QA | QMS | Process | Training and Learning | Compliance | Vendor Management | Clinical Research | GCP | Auditing | Inspections | GxP/GDP | Product Release | Global Pharma Biotech
Accomplishments
- Embedded quality, compliance, and continuous improvement culture into GxP functions, activities, and processes
- Built successful collaboration and partnership with internal GxP cross-functions and external 30+ high/medium-risk suppliers/vendors via self-inspections, and external quality audits to maintain compliance, and continuous improvement
- Led QMS and achieved distinguished quality and consistent compliance. Ensured product release in accordance with Quality Manual, Quality Agreements, regulations, procedures, and approved specifications.
Certification
ISO 9001: 2015 Lead Auditor (Quality Management Systems) Certification by CQI and IRCA, Bureau Veritas Certification
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote
Every problem is a gift—without problems we would not grow.
Tony Robbins
Timeline
Regional Quality Assurance Manager
ACINO
08.2019 - Current
Regional / Local Affiliate Process and Training Manager
ROCHE, Middle East Clinical Operations Hub
05.2015 - 06.2018
Local Quality Responsible-Egypt and Gulf Countries
ROCHE
06.2013 - 12.2017
Compliance and Training Officer / QA Manager
ROCHE
11.2012 - 05.2015
Senior Clinical Research Associate / Clinical Research Associate
ROCHE
08.2009 - 11.2012
Patient Educator
SANOFI
04.2008 - 08.2009
Post-Graduate Diploma - Clinical Pharmacy
Ain Shams University, College of Pharmacy
Bachelor of Science (BS) - Pharmaceutical Sciences
Ain Shams University, College of Pharmacy
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