Hussein Syed

About Hussein Syed

Experienced Professional working in Regulatory Affairs while maintaining compliance and meeting goals and deadlines for project deliverable\'s. Skills range from technical writing, project management, engineering quality assurance. Understanding analytical and technical skills in both science and business. Goal oriented, enthusiastic team member, driven by delivering quality results while achieving departmental and project goals.

Experience

1. Senior Manager, Head of Regulatory Systems Business Support

   Apellis Pharmaceuticals

   May 2022 — Present · Waltham, MA, US

   Administer end-user accounts and ensure appropriate access control/permissions to systems, collaboration spaces,and repositories. Provide support to global end-users by understanding and ensuring their needs are met and escalating morecomplex queries and issues Manage Department inquiry ticketing system (ARTS), and portal on Apellis Intranet Manage and ensure alignment of business processes and supporting systems Establish and maintain effective communication with end-users and other key stakeholders As an expert in RA technology systems functionalities, plan, manage, and deliver end user training to groups orindividuals, as needed Lead activities related to setting standards, best practices, KPIs collection and reporting, developing newprocedures and work instructions, and lessons learned dissemination Business lead for full implementation and maintenance of Apellis’ (Regulatory) electronic document managementsystem (EDMS) and managing workflows and templates. Work closely with IT and QA staff in ensuring the Regulatory technology systems always remain in a validated andcompliant (inspection-ready) state Business lead for upgrades and maintenance of regulatory systems ensuring successful deployment, includingvalidation activities (user requirements, UAT, processes, etc.) Main contact with vendors and service providers on systems related issue resolution, maintenance, and upgrades. Responsible for communicating system status and maintenance activities and liaise with IT and vendors onextended support, hyper care, business continuity and disaster recovery Manage activities related to exchange of information with partners (GRO counterparts) Assists with other GRO activities, as needed.

Education

• Boston University School of Medicine

  Bachelors of Science (BS), Biomedical Laboratory and Clinical Sciences

  2008 — 2012

• Northeastern University

  Masters of Science, Regulatory Affairs

  2012 — 2014

Skills

• Soft Skills
• 21 Cfr Part 11
• Validation
• Kaye Validator 2000
• Biotechnology
• Fda
• Molecular Biology
• Gxp
• Assay Development
• Project Management
• Glp
• Cell Culture
• Gcp
• Technology Transfer
• Gmp
• Good Documentation Practices
• Quality Assurance