Summary
Overview
Work History
Education
Skills
Certification
Accomplishments
Traits
Languages
Timeline
Generic

Adraa (Ady) Iskander

Phoenix,AZ

Summary

Proficient Global Compliance, Quality Systems and Data Analytics Director, who builds and motivates high-performing engineering teams. Extensive experience in compliance, quality systems, product quality manufacturing and regulatory audit leadership. Committed to innovative solutions driving quality compliance and business minded manufacturing efficiency in parallel. Passionate about continuous quality improvement and compliance growth in line with business and executive needs.

Overview

9
9
years of professional experience
1
1
Certification

Work History

Global - Director Compliance Data Analytics and CI

Fresenius Medical Care Holdings Inc.
10.2023 - Current
  • Leads the global Data Analytics and Continuous Improvement organization and activities enabling innovative compliance and enhancement of global processes and products.
  • Globally leads the business in their efforts to comply with all applicable state and federal laws and regulations.
  • Self-Monitoring, Data Mining and Risk Assessment programs for the assigned division.
  • Acts as the Privacy and Security Officer for the assigned division.
  • Attainment of cost reduction targets based on the deployment of pioneering data analytics and continuous improvement tools.
  • Ensures timely preparation, reporting and execution of global process improvement projects.
  • Directly supports the application of best-in-class global CAPA process investigations and execution.
  • Holds the authority to develop and deploy the global Data
  • Analytics and Continuous Improvement Strategy. Lead positive impacts on global financial results through the successful definition and improvement of cost of quality and cost of poor-quality opportunities.
  • Lead global expectation of the development, implementation and maintenance of CAPA, audit and regulatory compliance processes to adhere to a global continuous improvement and compliance.
  • Lead a global organization enabling efficient and effective quality improvements.
  • Oversee the capacity management and prioritization of the Data Analytics and Continuous Improvements Organization projects in line with the In Center Strategic priorities.
  • Build and deploy the Global Data Analytics and Continuous Improvement Strategy in line with and supporting the overall In Center strategic vision.
  • Develop, deploy and monitor key Data Analytics and Continuous Improvement performance indicators (KPIs).
  • Enhanced team productivity by implementing efficient scheduling and task allocation methods.
  • Enabled cost savings by identifying areas of improvement in resource allocation and process optimization.
  • Ensured compliance with industry regulations and company policies through regular audits and prompt corrective actions.
  • Championed sustainability initiatives within the department, leading to more eco-friendly operations without compromising output quality or efficiency.
  • Maintained high-quality standards by implementing rigorous quality control measures and providing relevant training to team members.
  • Implemented continuous improvement strategies that led to increased operational efficiency and reduced waste.
  • Developed strong relationships with cross-functional teams to foster a collaborative working environment.
  • Led cross-departmental projects that resulted in the successful integration of new systems or processes, enhancing overall company performance.
  • Created innovative solutions to architectural problems, enabling successful project completion.

Quality Systems Manager

West Pharmaceutical
06.2022 - 10.2023
  • Lead the Quality System and Compliance Organization, including Quality Engineers, Document Control Specialists and Compliance Engineers
  • Responsible for continuous enhancement of the Quality System through the deployment of effective processes and procedures while maintaining compliance to corporate, external regulatory and customer requirements
  • Manage/lead change requests across the quality and production systems
  • Site wide quality coaching on quality and regulatory requirements. Training on quality procedures across manufacturing and cross functional partners
  • Lead risk intelligent decision making when reviewing quality incidents impacting product and/or processes Lead remediation activities driving site level quality improvement plans Responsible for document control, quality systems, internal/external audits, quality strategic planning and execution and operational quality support
  • Develop, maintain, and report process and product quality performance metrics and reports thus identifying areas of mitigation or improvement
  • Lead or support the development and submission for product and site regulatory filings
  • Develop and lead interfaces/engagement with sister sites and/or Corporate to achieve aligned quality performance and monitoring Lead the development and submission of compliance audit responses to FDA, DEKRA and customers
  • Data analytics, quality management review and quality reporting.

Senior Quality Specialist

West Pharmaceuticals
03.2022 - 06.2022
    • Led and/or participates in ISO and corporate quality system audits
    • Led the investigation, identification of root cause analysis and resolution of NCRs, CAPAs, Complaints and Audit findings Lead cost saving projects Validation of processes including the introduction of new or enhanced product quality control plans Chair CAPA Review Board and Material Review Board Delegate for Site Quality Manager as required.
    • Monitored product standards and quality-control programs.
    • Completed deviation forms and recorded findings of inspection process, collaborating with quality team members and department managers to implement procedural remedies.
    • Analyzed quality and performance data to support operational decision-making.

Quality Assurance Engineer

Innovaquartz (Medical Device)
04.2018 - 03.2022
  • Lead implementation of new or changed processes/forms/documentation CAPA/NCR/DEV/CR/DCN/ Complaint Processing
  • Fixed identified issues to increase productivity and boost workflows.
  • External and external audit management for compliance to ISO and FDA Provides QA support for testing, and manufacturing activities for new products development in line with ISO and FDA requirements
  • Deployment of training on Quality Management System procedures
  • Produced and maintained technical documentation for project reference.

Area Director West Valley

In Home Tutoring Services
08.2015 - 08.2017
  • Customer facing lead for issue resolution of service improvement
  • Successfully managing the deployment of tutoring services across the assigned area
  • Relationship development, issuance, management and termination of customer contracts
  • Analyzed financial performance of area by monitoring budgets and expenses, reviewing financial statements and executing appropriate actions.
  • Conducted competitor analysis to highlight competitor strengths and weaknesses and forecast projected business.

Education

Master's in Business Entrepreneurship and Technology -

University of Waterloo, Canada
Waterloo Ontario
08.2008

Bachelor of Journalism and Mass Communication in JRMC -

The American University of Cairo, Egypt
Cairo Egypt
08.2007

Skills

  • Quality Engineering / Operations
  • Interpersonal /Decision-Making
  • Continuous Improvement /Data Analytics
  • Quality Management System
  • End to End Manufacturing
  • Quality Assurance Controls
  • Project Oversight and leadership
  • Regulatory Compliance
  • Budget Coordination
  • Staffing Oversight
  • Change Management Process
  • Quality Control Implementation
  • Sustainability Initiatives and Digital Transformation
  • Policy Implementation
  • Risk Mitigation and Problem Resolution
  • Workflow and Growth Planning
  • Procedure Implementation
  • Partnership Building
  • Business Case Development

Certification

  • ISO 13485:2016 Medical Device Quality Management Systems
  • ISO 19011:2018 Management Systems auditing
  • ISO 19011:2018 Leading Management Systems Audit Teams CQT
  • ASQ Certified Quality Technician, Certified Quality Engineer courses completed
  • EU MDR introduction course completed
  • Leading with Values Training

Accomplishments

  • Successfully led site through multiple FDA, DEKRA and NSAI pre and post approval inspections.
  • Global lead on harmonization of QMS processes (CAPA, NCR, Complaints, Doc Control, Audits, Supplier Quality) across multiple sites.
  • Quality Lead for targeted multi million dollar remediation programs.
  • Selected for quality development program - Future Quality Leaders

Traits

  • Entrepreneurial
  • Hard Working & Committed
  • Creativity & Innovation
  • Team player
  • Execution

Languages

Arabic
Native or Bilingual
French
Native or Bilingual
English
Native or Bilingual

Timeline

Global - Director Compliance Data Analytics and CI

Fresenius Medical Care Holdings Inc.
10.2023 - Current

Quality Systems Manager

West Pharmaceutical
06.2022 - 10.2023

Senior Quality Specialist

West Pharmaceuticals
03.2022 - 06.2022

Quality Assurance Engineer

Innovaquartz (Medical Device)
04.2018 - 03.2022

Area Director West Valley

In Home Tutoring Services
08.2015 - 08.2017

Master's in Business Entrepreneurship and Technology -

University of Waterloo, Canada

Bachelor of Journalism and Mass Communication in JRMC -

The American University of Cairo, Egypt
Adraa (Ady) Iskander