Haitham Hesham

Jeddah, Saudi Arabia +966********* +201********* ad1bcp@r.postjobfree.com

(Transferable Ikama)

Dears,

With more than 10 years of services in the Pharmaceutical Industrial space across multiple roles with increasing responsibilities, I’m extremely interested to join your team in this new challenging opportunity for the role you posted.

In addition to my expertise in Quality Management Systems (QMS), Product Transfer and Regulatory/Compliance, I am actively involved in initiatives and efforts Supporting requirements gathering, prioritization and delivery of enhancements to ensure that the compliance positioning of DPS is accurate and Customer experience is best in class.

Thus, I am committed to embrace the challenges involved with the role.

A sample of my achievements throughout my career journey include:

Successful Lab Startup of Pfizer KAEC Site, Saudi Arabia.

GMP licensing of KAEC site, Saudi Arabia by Saudi FDA.

Leading project teams to Successful Deployment and Validation of first Quality Systems.

Leading Quality & technical assessments including appropriate enquiries replies for first 7 full manufacturing products for Pfizer Saudi submitted to local regulatory (Saudi FDA).

Working at a regional level in matrix organizations and global quality projects with cross functional collaboration.

Establishing Continuous improvement Councils supporting Core solutions initiatives, programs, processes, and governances within Pfizer network.

Culture Change by successful launching & Influencing of Data Integrity program principles within Pfizer KSA site.

Leading Global Quality Councils & Forums focusing on quality strategy implementing standards, policies and strategies developed at regional and global level within Pfizer network.

Successful implementation of Remediation quality compliance program for LSM network.

Supporting focused Internal Audit programs with implementing effective CAPAs leading to successful regulatory and corporate audit outputs.

Leading Technology & Analytical Method Transfer projects for Pfizer KAEC site.

Six Sigma Yellow Belt project for improving site quality supplies timeline.

I am looking forward to discussing with you in more details how my skills and expertise could apply to the proposed role and offer me a platform for growth.

I have attached my resume that offer a more comprehensive summary of my carrier for your review.

Thank you for your time and consideration.

Best regards,

Haitham Hesham

Haitham Hesham

+966********* +201********* ad1bcp@r.postjobfree.com

A Quality Operations section head with 10+ years of experience in Pharmaceutical Manufacturing, Quality, and Compliance Systems. Skilled in driving the development and maintenance of compliant Core Solutions as they deploy and use QC Solutions.

Gained experience in Team Leadership, Change Management Accountability, and Stakeholder Engagement.

Areas of Expertise:

Site Start Up Quality Systems Compliance Project Management Computerized system Validation Core Solution Deployment Quality Control Data Integrity Technology Transfer Team Building & Coaching Inspection Readiness Regulatory Submission Continuous Improvement cGMP PHP Investigations Internal Audit NTM OPEX CAPA management GxP Auditing

Career Highlights:

-Project leader of Data Integrity Security Tools (as Deskman, Systrack) implementation in Pfizer KSA site

-Led Project for NueGenesis system implementation for Backup and restore in Pfizer KSA site.

-Led Project for Empower 3 system implementation for Chromatography analysis in Pfizer KSA site.

-Managing Submission projects for regulatory (SFDA) approval of first 7 full manufacturing products for Pfizer Saudi

-Won “PGS Bold Move Award” for Decreasing Human errors by 50% for quality related activities.

-Won “PGS Bold Move Award” for Enhancing product release timeline by decreasing documentation by more than 30%.

-Won “PGS Bold Move Award” for Improving Audit Trail Review Process for enhancing Data Integrity & Compliance Requirements

PROFESSIONAL EXPERIENCE

Pfizer Int’l Pharmaceutical Corporation

Global Quality Systems and Compliance Manager 05/2022-Till present

Provide strategic compliance oversight and manage Quality business process for different Quality Systems across Pfizer network.

Support PGS sites as the Business Process subject matter expert and Voice of the Customer (VOC) for Quality Control Labs, Quality Assurance and other functions.

Manage multiple global quality projects and compliance initiatives.

Innovation, maintenance of standards, business process development and maintenance for processes that are supported by Digital applications.

Providing QO ownership of global procedures and standards with Supporting EMEA region in addition to AMER and APAC as needed.

Leads User Councils and Continuous Improvement Councils to ensure that knowledge and experience acquired is transferred to other team members.

Effectively communicate and drive changes across PGS site and Center functions to achieve industry leading performance.

Provide Quality and business owner input during board of health audits, change controls and internal investigations related to the systems we support.

Pro-actively reads and extracts developing regulations and trends from available sources to provide recent perspectives during audits.

Quality Operations & Compliance Section Head 09/2015 – 04/2022

Established the Start-up projects for a new plant in Saudi Arabia including Quality Systems Implementation, Qualification, and business continuity.

Leading Global Quality forums within LSM network for assuring the compliance of our systems from a Data Integrity, ERES, and regulatory aspects for the lifecycle of our systems.

Support, guide and challenge the work during the preparation of deviations, change requests, Corrective Action and Preventive Action (CAPA), and systematic problem-solving.

Managing Cleaning, Process Validation and Stability Study activities withing QC area.

Act as SME for Quality/ GMP compliance issues at the site and Nominated to support other Pfizer sites in region to maintain optimal regulatory & quality compliance levels and archives in all regulatory aspects.

Oversee and guide lab analysts on continuous improvement tools such as standard work and visual management.

Ensure alignment to all regulations and Pfizer Quality Standards related to area of oversight and work with other management teams to ensure support of equipment/instruments for all testing activities in the routine testing area.

Participation in local Site Self-Assessment (internal audit) teams to focus on potential areas of inspector inquiry and Support inspection readiness plans and interact with regulatory agencies during inspections.

Review and approve documentation associated with Good Manufacturing Practices, equipment validation/qualification, investigations, change controls and technical reports.

Working with the cross functional technology transfer governance & Provide information, discuss problem/technical issues, deviations and other events with potential impact on product quality and/or supply.

Strategically influence Compliance & DI program in alignment with internal and external learnings and requirements.

Oversee project management of all Data Integrity related activities with the relevant teams.

Pfizer Int’l Pharmaceutical Corporation – Cairo, Egypt

Quality Operations Specialist 08/2014 – 09/2015

Responsible for Systems Qualification/Validation/Calibration, Stability Programs, and product release.

Global Napi Pharmaceuticals – Cairo, Egypt

Quality Control Specialist 08/2010 – 08/2014

Responsible for testing, Qualification, and calibration for quality systems

EDUCATION

Master of Business Administration (MBA) degree in Emotional Intelligence - ESLSCA 2014

Bachelors of Pharmaceutical Science – Cairo University 2009

TECHNICAL CERTIFICATIONS

Pfizer Certified Six Sigma Yellow Belt (M1)

Pfizer Certified Auditor

Pfizer Certified Train the Trainer

Pfizer Leadership at every Level

Competency Skills

Strong interpersonal and influential skills Analyzing Complex Information Self-motivated Energetic Resilience Innovative Strong Communication skills Problem Solver Remote management Negotiation

LANGUAGE PROFICIENCY

Arabic: Native

English: Full Working Proficiency

French: Limited Working Proficiency

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