Wageeh Gerges Email & Phone Number

Managed quality oversight for drug substance/product manufacturing activities, including timely review of PPQ, batchRelease for GMP manufacturing commercial production and packaging operation •Interacted with key stakeholders such as CMC, Analytical Chemistry/QC, Supply Chain, CMO Management, and Regulatory Affairs to ensure clinical and commercial drug products were manufactured following established procedures, cGMPs, and appropriate regulatory requirements, resulting in consistent product quality •Championed continuous improvements in quality assurance operations, leading to the timely resolution of quality issues with external vendors/CMOs and supporting CMC and regulatory submissions •Reviewed and approved SOPs, QT Agreements, Internal and external audit reports, test methods, OOS, CAPAs, and product complaints, efficiently managing change control for adequate and timely closeout of these events, ensuring compliance and operational efficiency•Led and interfaced with external contract manufacturers to address and resolve complex product/process performance issues (PPQ), tech transfer, commercial production, adhering to QMS, and maintaining lifecycle quality •Supported milestones for projects linked to contract manufacturing oversight and QMS, involved in EBRs, PPQ, tech transfer, scale-up, Change Control, Deviations/OOS, CAPAs, and vendor management processes.•Collaborated on project management within the quality scope and timeline, utilizing electronic QMS platforms and fostering relationships to ensure product quality

Boston, Massachusetts, United States

Served as Senior QA support and SME for Drug Substance, Drug Product, QMS, and Finished Product manufacturing processes of the COVID-19 vaccine • Established and maintained an annual Supplier Audit Schedule. Conduct Supplier Quality Audits for new suppliers (as required) to determine adherence to acceptable quality practices. Maintains supplier management metrics and issues monthly metric (KPI) reports. Periodic reviews of approved supplier list• Collaborated with internal cross-functional impacted areas, such as QC, Validation, Clinical Supply, CMO Management, CMC/Regulatory Affairs, and Technical Services, to resolve open issues promptly resulting from record reviews and deviation events• Collaborated with the CMO team to plan, manage, and drive project activities within the agreed quality scope and timeline to build relationships, meet customer expectations, and ensure the product quality

Philadelphia, Pennsylvania, United States

Led all GSK quality activities as primary Quality Assurance contact at the CMO for circumstances involving PPQ, OOS, deviations, CC, Quality Agreements, lot disposition, and release activities within established specifications and timeframes to meet customer commitments (2)• Reviewed testing of RMs, DS, and DP release specifications, deviations, CAPA, EBRs, CC, COAs/COCs, customer complaints, and manufacturing and packaging batch records• Demonstrated solid experience in supporting QMS, drug development (APIs), Clinical studies (phase I- III), commercial manufacturing and packaging/labeling operations, analytical and micro testing, equipment validation, PPQ, cGMP training, and quality systems• Collaborated cross-functionally to build relationships, meet GSK SOPs, and ensure the product was manufactured right the first time• Provided QA leadership to ensure thorough actual root cause investigations and effective corrective actions to prevent recurrences. Collaborated with department leaders to ensure effective CAPA to meet regulatory requirements

Albany, New York, United States

• Acted as a liaison between CDMOs, suppliers, purchasing, QMS, technical services & validation, and manufacturing to resolve divisions and site quality issues • Performed batch record review, including QC testing results, investigation, and CAPA • Led Internal and supplier & CMOS evaluation of the audit program to support the qualification, selection, approval, and monitoring of supplier and manufacturing partners

Morgantown, Pennsylvania, United States

• Led the site's quality assurance programs and assisted with the site's training and auditing (internal and external) programs, as well as the review of investigations, CAPAs, OOT, specifications, validation reports, QMS, and manufacturing records• Managed, scheduled, led, and acted as a subject matter expert in internal and external audits, site inspection readiness programs, gap analysis, mock audits, and risk assessment

South Africa

• Served as the quality decision-maker on all quality-related issues arising from product quality. Managed site activities related to Aspen Pharmaceutical and met the milestones • Managed the site's quality assurance program and assisted with the site's training and IA / Ex auditing programs, as well as the review of PPQ, investigations, specifications, CAPAs deviations, OOS, and validation reports, manufacturing, and packaging batch records• Served as a primary point of contact for the CMOs to support batch manufacture, deviation, investigation, PPQ, finished product release, QMS, and logistics• Hosted and followed up on FDA and MHRA inspections and Global and External vendor audits to ensure comprehension of CAPA and reviewed all related records

India

• Managed site activities related to customer complaint handling (239) and CAPA program (401 CAPAs), including the root cause analysis, CAPA plan development, verification of completion/ effectiveness, and timeliness of the site's CAPA activities• Provided leadership, strategic insight, direction, and implementation for all quality assurance activities, resulting in continued product improvement and compliance

Lancaster, Pennsylvania, United States

Collaborate with internal and external stakeholders to ensure compliance with all relevant regulatory bodies. Identify potential risks and develop mitigation strategies to ensure product quality and safety.• Managed and led internal and external quality audits, CMOS, CTLs, APIs, suppliers, GMP Service providers, PPQ, and packaging component contracts• Led core project teams and R&D functions to identify supplier needs and leverage the company's existing supplier network for optimal effectiveness. (3)• Collaborated with Contract Manufacturing Organizations (CMOs) to plan, manage, and drive project activities within the agreed quality, scope, and timeline and execution of CAPAs about any nonconformities cited during audits • Provided direction and critical review of qualification and periodic monitoring of 3rd party GxP vendors to ensure quality outsourcing partnerships• Established effective partnerships with all departments so that quality systems and compliance activities are well understood and executed to high standards• Built, organized, and maintained inspection readiness program, site mapping zones, and documents to ensure quick access during inspection

Lynchburg, Virginia, United States

• Supervised and provided QA review lot disposition and release activities for drug products within established timeframes to meet customer commitments.• Interfaced with vendor suppliers and CMOs to identify and solve technical deficiencies

Lynchburg, Virginia, United States

Demonstrated experience establishing and managing day-to-day quality and compliance programs and activities in a manufacturing plant • Assisted in support and submission of first medical device class 1 in a new line of business • Provided leadership and guidance to Quality, Manufacturing, and R & D

Forest, Virginia, United States

Managed regulatory agency responses, commitment tracking, and time frames. Continuously improve the GMP /Regulatory Agency Inspection management and readiness processes, driving implementation across Teva’s sites• Demonstrated solid experience in supporting drug development (APIs), NDAs, ANDAs, Clinical studies (phase I- III), commercial manufacturing, analytical and micro testing, equipment and cleaning validations, cGMP training, PPQ, cGMP training, and quality system• Provided QA guidance and support for supplier & CMO qualification, scale-up, OOS, CAPAs, CC, APRs, and other GMP activities manufactured by CMOs• Hosed and followed up on FDA, Canadian, and MHRA inspections and Global and External vendor audits to ensure comprehension of CAPA and reviewed all related records • Led cross-functional team to investigate OOS/ CAPA. Initiated deviations and prepared clear, concise reports on outcomes of investigations• Escalated site compliance risks promptly and provide leadership toward resolution• Identified and Alerted the corporate management of any potential risks promptly and provided leadership toward resolving site compliance risks• Fostered ability to work effectively and provided quality direction to all levels of management to implement action plans and improve product quality

New Jersey, United States