Stephen Weil

Background

About Stephen Weil

At A Glance FDA and EU Regulations, including, but not limited to 21CFR11, 820, Safe harbor, PDMA Strategic- Planning of activities and operations related to validation, quality control and assurance Develop and implement policies, standards and procedures for the engineering and technical work performed by the QA department Managed team to consult and negotiate with clients to prepare specifications, explain proposals and present engineering reports and findings as well as P&L responsibilities Recruit personnel and oversee development and maintenance of staff competence in required areas Participate directly in the design, development and inspection of technical projects SME for pharmaceutical industry and GxP requirements as well as other regulatory guidelines and requirements Broad based engineering foundation in process, hardware and software systems, including SAP Highly proficient communicator effective at managing relationships between strategic leadership, third-party vendors, and clients Plan, organize, direct, control and evaluate the activities and operations related to quality control and assurance Develop and implement policies, standards and procedures for the engineering and technical work performed in the department, service, laboratory or firm Quality management for Life Sciences (Pharmaceutical, Medical Device and Biotechnology companies) Write SOPs, Directives and WI Document Management System Integration Organizational Leadership GAMP 5 ISO ITIL CMC SDLC SAP Team Development Sarbanes–Oxley (SOX) Infrastructure Qualification (hardware) Regulatory Compliance IM Security Validation Corrective Action Preventative Action (CAPA) Audit Training Pre and post sales support and Training