Amer Alghabban

Leveraging my expertise to ensure quality and compliance, focus on enhancing inspection preparedness. Key Responsibilities: •Lead high-risk submissions, conduct risk assessments, mock inspections, & develop tools for global R&D inspections •Quality Management: Address critical quality aspects, assess risks & develop mitigation plans •Direct regulatory inspections, coordinate responses & manage CAPA •Implement preventive measures & streamline processes. •Build relationships, mentor staff & provide GCP advice

Audits & Training on GCP, GCLP, GLP, GDP & GVP systems. Inspection Support & Responses to Reg. Auths. Formal QA Representation, Risk Management & Eval. SOP Development & Review. Essential Documents (Protocol, Study Reports, ICF, etc.) Compliance audits. FDA 483 Response support. Mock GCP & GVP Reg Auth. Inspections.ISO 9001:2015 Audits. Clin Dev & Pharmacovigilance Gap Analysis. Inspection Support. Review of IB, IMPD, Clinical Protocols, ICFs, CSRs, QM, TMFs. Compliance reviews of promotional materials

SME on GxP & provide guidance to within Clin & QA. Training to Pre-Clinl, Clin and non-clinical Dev staff. Ensure Tech Ops & CROs provide oversight into process design, scale-up. Ensuring process, analytical & formulation Dev work are managed at CMOs. Manage staff. Oper’ strategy in Clin & CMC Quality dep. Manage strategic/compliance risk assessments, Metrics & CAPA. Liaise with Clin Dev, CRO, & Clin QA to support GCP, GMP & GVP Inspection readiness. Strategic oversight plan

•Manage the global audit team responsible for the development, implementation & follow-up of audit programs for Global R&D activities. •Establishment & implementation of a risk-based, dynamic, audit program, •Management of compliance of global clin development activities with GCP & regulatory requirements, & regulations. •Review & approve the audit resourcing & allocation to ensure that they are designed to positively support the goals & objectives of the Global R&D QA.^ etc

Responsible for: 1.Quality Management System (QMS) 2.Assessment of regulatory compliance of Research & Development, GCP, GLP, GMP & safety reporting activities & processes (internal & Contracted) 3.Assessment of regulatory compliance of Research & Development activities & processes (internal & Contracted) 4.Facilitation, Preparation for & Hosting Regulatory Inspections (GCP, GMP, GLP, & GPP): hosted 14 different inspections from FDA & EU Regulatory Authorities 5.Managing the vendor selection