Summary
Overview
Work History
Education
Skills
Timeline
Generic

Sussan Ekejiuba

Riverdale,MI

Summary

Team Leader experienced in directing activities of workgroups. Develops strategies, provides training, sets goals and obtains team feedback. Excellent interpersonal and communication skills. Big picture focus with excellence in communicating goals and vision to succeed. Problem solver, networker and consensus builder.

Overview

20
20
years of professional experience

Work History

Team Lead

US Food & Drug Administration (FDA)
2022.03 - Current
  • Increased customer satisfaction by ensuring timely completion of projects and adherence to high-quality standards.
  • Supported creation of detailed, technical financial models to value potential acquisition targets.
  • Established clear performance metrics for the team which helped in tracking progress towards set targets effectively.
  • Minimized resource and time losses by addressing employee or production issue directly and implementing timely solutions.
  • ·Organize and Conduct Team Meetings. Communicate organization goals, & expectations to team members. Breakdown work processes and requirements to team members.
  • ·Represent Center at FDA Center -wide meetings and workgroups, and WHO representatives’ meetings.
  • ·Managing Exports IT Contracts: Engagement of IT Contract Representative.

Program Director / Data Analyst

Global Health And Education Projects (GHEP), Inc.
2011.03 - Current
  • Conduct public health research that increased number of peer reviewed research articles received for publication in the two journals owned by the organization.
  • ·Project Manager for Community Diabetes Prevention Education Project leading to a significant reduction in participants’ A1C levels over 3 months of participation.
  • ·Managing Free Diaper Distribution of PG County, a giving back project by the GHEP, to assist parents in need of clean baby diapers within the surrounding neighborhoods of Prince Georges County, MD.Developed and recommended policies and procedures for evaluating programs.
  • Analyzed viewer data and adjusted programming lineup to maximize potential viewership.
  • Developed and implemented marketing strategies to promote program awareness and participation.
  • Established program policies and procedures to comply with regulatory requirements.

Acting Chief

US Food & Drug Administration
2022.08 - 2022.12
  • Proven ability to develop and implement creative solutions to complex problems.
  • Organized and detail-oriented with a strong work ethic.
  • Developed and maintained courteous and effective working relationships.
  • Developed strong organizational and communication skills through coursework and volunteer activities.
  • Leading agency-wide electronic export certificate reformation to match the new World Health Organization format. Implemented the recommended format which other centers are using to modernize their center’s export certificates formats.
  • Managing Team: Conducting Branch Meeting. Providing weekly reports to division directors of Team performance, successes, challenges, and bottlenecks.
  • Strategic, Operational and Quality Management (SOQM): Creating appropriate Key Performance Indicators (KPIs) to manage performance in projects, programs, and work processes of high visibility; using the KPI to demonstrate team progress in achieving the goals. Retiring KPIs that have been met and creating new ones to match highly changing organizational priorities.

Quality Assurance (QA) Manager

US Food & Drug Administration
2014.12 - 2022.03
  • Established and tracked quality department goals and objectives.
  • Specified quality requirements of raw materials with suppliers.
  • Enhanced product quality by implementing rigorous testing procedures and protocols.
  • Collaborated with stakeholders to establish key performance indicators for the QA team, driving continuous improvement efforts throughout the organization.
  • Review & approve 400 - 450 export certificate applications monthly resulting to 30% increase in organization’s annual revenue from certificates for exportation of pharmaceutical products.
  • Subject matter expert review of manufacturing facilities’ inspection statuses.
  • Conduct compliance review of drug labels, drug approval documents, and other supporting documents provided in export certificate application package.
  • Served as Independent Objective Grant Reviewer for RFA-FD-15-023 “ISO/IEC 17025:2005 Accreditation for State Food Testing Laboratories (U18)”, June –July 2015.
  • Served as Chairperson, Objective Review Committee for RFA –FD-17-10 Cooperative Agreement Program Maintenance and Enhancement of ISO/IEC 17025 Accreditation and Whole Genome Sequencing for State Food Testing Laboratories (U18), July 2017.

Senior Regulatory Specialist

DAIDS Regulatory Support Center - TRI
2010.03 - 2014.10
  • Developed strong relationships with key stakeholders including regulators, industry peers, and clients to advance collaboration efforts.
  • Conducted thorough risk assessments, identifying potential issues and proactively implementing solutions.
  • Managed post-marketing surveillance activities, tracking adverse events, product complaints, recalls, or other relevant information as required by law.
  • Assisted in the preparation of high-quality reports detailing findings from regulatory inspections, ensuring clear communication of outcomes and required actions.
  • Provide regulatory support for over 350 clinical protocols from development to implementation, including performing regulatory reviews to ensure compliance with Federal regulations and client requirements.
  • Participate in the implementation of clinical protocols for the division of AIDS sponsored clinical trials, and work with DAIDS medical officers (MOs), sponsor’s authorized representatives (SARs) and Branch Chief to resolve major issues relating to protocol development, regulatory review, new IND application and submission to the FDA, and to other regulatory entities outside US.
  • Providing support on behalf of DAIDS to clinical trial sites in US and overseas, including relevant expertise advice in clinical trial implementation and management, informed consent, and data entry/quality assurance, and participate in the development of regulatory manuals, SOPs and guidelines for regulatory activities.

Laboratory Manager: Specialized Neuroscience Lab

Howard University
2004.09 - 2009.05
  • Assisted in grant writing efforts, securing funding for research projects and equipment purchases.
  • Coordinated staff training programs to keep abreast of advances in scientific knowledge relevant to the field.
  • Maintained an organized inventory system for lab supplies, reducing waste and saving on procurement costs.
  • Improved laboratory efficiency by streamlining workflows and implementing process improvements.
  • Developed a montage of three nerve bundles in cat vagus nerve.
  • Developed laboratory SOPs/manuals for development of vagus nerve montage.
  • Train Lab technicians/ post-doctoral fellows and trainees on lab skills

Education

Master of Science - Data Analytics

University of Maryland Global Campus (UMGC)
Adelphi, MD
05.2023

PMP Certification - Project Management

Technical Institute of America
New York, NY
10.2014

Public Health

The University of West Florida
Pensacola, FL
09.2013

Ph.D. - Pharmacology

Howard University College of Medicine
Washington, DC
05.2009

Doctor of Veterinary Medicine - Veterinary Medicine

University of Nigeria
Nsukka, Nigeria
01.1999

Skills

  • Coaching

  • Regulatory Compliance

  • Audit reporting

  • Team motivation

  • Improvement plan knowledge

  • Performance monitoring

  • Process Improvement

  • Issue Resolution

  • Coaching and Mentoring

  • People Management

  • Schedule Management

  • Giving Constructive Feedback

  • Project restructuring

  • Mentoring

  • Goal Setting

  • Conflict Resolution

  • Onboarding and Orientation

  • Program Evaluation

Timeline

Acting Chief

US Food & Drug Administration
2022.08 - 2022.12

Team Lead

US Food & Drug Administration (FDA)
2022.03 - Current

Quality Assurance (QA) Manager

US Food & Drug Administration
2014.12 - 2022.03

Program Director / Data Analyst

Global Health And Education Projects (GHEP), Inc.
2011.03 - Current

Senior Regulatory Specialist

DAIDS Regulatory Support Center - TRI
2010.03 - 2014.10

Laboratory Manager: Specialized Neuroscience Lab

Howard University
2004.09 - 2009.05

Master of Science - Data Analytics

University of Maryland Global Campus (UMGC)

PMP Certification - Project Management

Technical Institute of America

Public Health

The University of West Florida

Ph.D. - Pharmacology

Howard University College of Medicine

Doctor of Veterinary Medicine - Veterinary Medicine

University of Nigeria
Sussan Ekejiuba