Youssef Awad

• Leading Roche Ireland local Medical Compliance across the affiliate admirably, dividing time between serving as a functional leader as affiliate LQR, as well as being a supportive technical expert across multiple disciplines.
• Have been recognized as an expert by all that work with me, and my contributions (skills/capabilities and mindset/behaviors) have noticeably improved the work across other local functions such as Safety, Clinical Operations and Regulatory.
• Supporting the affiliate beyond own scope by being a leader / working on the delivery for vendor oversight, SPOT and local learning expert, including supporting the ACT with local training adherence - a key STO for Irish affiliate in 2024 year.
• Having a positive impact been felt across all aspects of local medical compliance and oversight (including, but not limited to, RMM, APS, Vendor management, IVDR, Clinical Operations).
• Leading local procedural document simplification initiative in Ireland since 2022 until now. That helped to reduce the number, and severity of locally reported deviations, issues and findings - a key measure of effectiveness. In addition to that local support, recognized as an expert by, and invited to collaborate on work with, regional colleagues (North Atlantic Alliance of LQRs), as well as other LQRs in the network. Also, regularly contributes towards global work packages also, such as the SIRIUS dashboard implementation, OneQMS for PD, GCP/GVP Training CoP, GxP LtO Onboarding material.

• Ensure Market Research and Patient Support Programs (MAPs) are initiated and executed according to applicable quality standards by the respective MAP Owners.
• Acting as a single point of contact for the Global Team as well as ensures cross functional collaboration with local quality responsible, PV approver, local safety unit, legal and procurement where applicable.
• Support the organization (activity/program owners) in the identification and classification of all activities that could potentially qualify as MRPs or PSPs. Support the MAP Owner during the process for selection and qualification of Service Providers.
• Oversee setup and creation of the MAP including accurate tracking in the MAP tracking system. Review MAP metrics monthly and ensure that non-compliances are documented and managed according to the CSFM Process confirming that the relevant parties implement the activities within the MAP tracking system and all relevant activities are completed as scheduled.

• Leads and manages the strategic and operational performance of the Quality Management System (QMS) at affiliate level, ensuring the successful delivery of the Global Quality Strategy, in alignment with annual Quality Objectives, whilst maintaining oversight and adherence to local regulatory requirements.
• Promotes a quality culture that ensures the highest standards of Quality and Medical Compliance. Proactively monitors and oversees external regulatory changes affecting affiliate quality and compliance.
• Drives the Affiliate Management Review Process ensuring that key quality or compliance issues are communicated effectively to senior management and appropriate actions are taken. Identifies and works in partnership with key affiliate stakeholders and QCCL to maintain quality standards and to support continuous improvement in the Affiliate.
• Leads the Risk Management Process for Medical Compliance at local level to proactively identify, manage and treat risks in order to support the business objectives of the local organization. Drives and enables the overall CAPA Management process at local level.
• Support the PDQ Quality Assurance global strategy by providing affiliate insights. Coordinate and/or support, in collaboration with PDQ, the preparation, execution and CAPA response to the Audit and Inspection findings impacting QMS and GCP/GVP regulatory compliance.
• Lead Inspection Readiness activities/initiatives for GCP/GVP inspections according to needs. Undertake other quality responsibilities that may arise in emerging Quality areas (e.g. Healthcare Solutions, RWE, medical devices) as per business needs.

• Leading a local team of almost twelve MAP owners with commercial background in Roche Saudi Arabia. Leverage quality mindset throughout both the global and local MAP processes.
• Leading tens of Saudi MAPs including 2 regional projects across Middle East affiliates and set up the first Patient Support Program for Evrysdi product in collaboration of Global MAP team.
• Mitigating all MAP process related risks by overseeing setup and creation of the MAP including accurate tracking in the MAP tracking system.
• Develop and maintain local guideline based on the global process update.
• Provide regular MAP status updates, highlight potential risks and escalate issues accordingly to both LMCO and MR meetings.

Support the Gulf Countries Cluster (Kuwait, Oman, Qatar, Bahrain, Yemen) in the following Quality responsibilities until a new LQR was hired:

• Leads and manages the strategic and operational performance of Medical team at affiliate level (ARUF, Local GRIDs/LITs, Training Completion Compliance Metrics)
• Ensure proper Service Provider Management (SPTLog, QACL, SPOP) for GCP/GVP (both MAP and non-MAP) Service Providers.
• Drives and enables the overall CAPA Management process at local level (SIDs/Audit/Inspection).
• Ensures the implementation of global processes and process improvement initiatives in their affiliate with the necessary local subject matter experts in collaboration with the QCCL (DAS, BPS, Procedural Life Cycle Management).

• Provides critical oversight of the CSFM process, verifies execution of the CSFM Quality Strategy and reviews and approves process outputs at key points in the process.
• Being a point of contact for stakeholders and Senior Management in sharing key data and performance metrics to drive compliance standards upwards.
• Develop and analyze data for Global PV Related Process Deviations (12 Month) & Quarterly Trending Report which was presented to QPPV Office on 27-Aug 2020 after working closely with GPOs and GPQRs to identify risk areas and determine the mitigating actions necessary to minimize gaps in their processes.
• Liaise with end-users and provide them with tools, reference material and build awareness to drive actions.
• Downgrading of 22 QEV/FIN records into Minor or OOS on the Quest System following the relevant process then develop a trending report and shared with PDQ-QAP to enhance the CSFM process.
• Raised and led almost 20 topics for discussions with Lead/Specialists team members on dedicated weekly calls (3 different setup). Actively participated in all Team call and interactions.
• Evaluated validity of 12 QEVs received from Global Functions (PDG, PDS, PDR) before assign to relevant QRs to manage on the Quest system.
• Completed 3 days training of Quest Analytics (Tableau, BI) and leveraged learnings to complete item 1 on the list (Trending Report for QPPV and GVPc).
• Participated in CSFM Clinics to QRs during the Planned Deviation period and after returning to normal process was the contact person within the CSFM team for many Quality colleagues. Selected as a Part of CSFM Lifeline Team to support all affiliates QRs in evaluation, classification and assessment of criticality of Findings.

• Responsible for anti-HER2+ Breast Cancer products (Herceptin, Perjeta, Kadcyla) and Cancer Immuno-therapy in Triple negative breast cancer (Tecentriq) in Medical Team, Roche Saudi Arabia.
• Responsible for cultivating and maintaining relationships with thought leaders, presenting information and responding to physicians and other healthcare professionals’ medical inquiries and participate in different KOLs Engagement Plans: Speaker Development Program, Train The Trainer Program, Advisory Boards, National / International Conferences, CME & Clinical Projects.
• Participating in preparations and discussions of Annual Integrated Brand Plan (AIBP) and Tactical Plans. Responsible for Quality in executions (internal Monitoring Outcomes/Audit progress report) through excellent post-event surveys, archiving/documentation for all 2017/2018 medical activities / MSL tactics / RIME and top performer in CRM KPIs among all MSLs, collaborates with LSR for pharmacovigilance Adverse Events and Special Situations reporting followed by monitoring team auditing with highly recognition and no findings were reported.
• Support LMA/PDMA/PDG studies and landscaping to enhance site's performance and quality through extra milestone in investigators continuous communications pre- and during recruiting patients that was highly appreciated from clinical operation team to resolve any query as well as carrying innovative approaches.