Mohanad Ali · Qualified Person
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Mohanad Ali
Corporate Quality Responsible at SpectroPharma
PreviousSite Quality Responsible (QP) & QA Manager at SPIMACO Addwaeih
EducationMS, Pharmaceutical Manufacturing — Stevens Institute of Technology
01
About Me
Pharmaceutical Quality Executive
GMP · QMS · Validation
Regulatory Affairs
GMP · QMS · Validation
Regulatory Affairs
Accomplished pharmaceutical quality executive with over 15 years of experience leading GMP-compliant QA/QC operations, validation programs, and regulatory affairs. Recognized Qualified Person (QP) by SFDA with a proven track record in digital QMS transformation (SAP HANA, LIMS, ATTP).
Successfully managed multi-site audit readiness, vendor oversight, and high-potency manufacturing validation — consistently elevating compliance, reducing CAPA cycle times, and enhancing product release timelines, aligned with SFDA, EMA, WHO, and GCC standards.
0.37%
Market complaint rate — 19 of 5,164 batches
117
Deviations closed, CAPA cycle time cut 30%
≤5 days
QC lead time incl. microbiological testing
2×
Microbiology sampling throughput increase
12
High-potency QC instruments qualified
02
Experience
REF · QP-05 / SPECTROPHARMA
Director of Quality / QP
SpectroPharma, Sudair, Riyadh, Saudi Arabia
Sept 2025 — Present · 10 MONTHS+
CURRENT ROLE
Leadership of Integrated Quality Operations
- Directed cross-functional Quality Assurance, Quality Control, Validation, and GMP Compliance functions, aligning plant-wide quality strategy with corporate vision and ensuring robust adherence to SFDA and international cGMP standards.
Governance of QMS & Regulatory Compliance
- Led governance of QMS and data integrity systems, driving alignment with 21 CFR Part 11 and Annex 11. Oversaw internal/external audits, regulatory inspections, and technical documentation (SMF, VMP, SOPs).
Quality Risk Management & Continuous Improvement
- Implemented risk-based methodologies (ICH Q9, Annex 15) to proactively manage deviations, CAPAs, and audit findings; streamlined quality review workflows through lean initiatives.
Strategic Supplier & CMO Oversight
- Evaluated and improved supplier and CMO quality systems, ensuring compliance for raw and packaging materials, and extended technical oversight to international partners.
REF · QP-04 / SPIMACO ADDWAEIH
Site Quality Responsible (QP) & QA Manager
SPIMACO Addwaeih, Buraydah, Qassim, Saudi Arabia
April 2015 — Sept 2025 · 10 YEARS 5 MONTHS
RELEASED
Led end-to-end quality operations across a decade of progressive roles culminating in Site Quality Responsible and QP status — overseeing integrated QA, QC, validation, and GMP compliance at a complex manufacturing site, and licensed for batch release across all stages of the product lifecycle.
Quality Governance & Compliance
- Managed implementation and oversight of electronic QMS and data integrity systems (SAP HANA, LIMS, ATTP), ensuring alignment with 21 CFR Part 11, Annex 11, and SFDA Part I GMP requirements.
- Maintained a state of audit readiness; successfully hosted regulatory inspections (SFDA, EMA, GCC) and global licensors (GSK, Pfizer, AZ, Sanofi) with minimal observations.
QP Authority & Batch Release
- Held full QP responsibilities including compliant batch certification, documentation review (BMRs, CoAs, deviations), and final disposition authority.
- Collaborated with Production, QC, and Warehouse to reduce batch release timelines through MES-integrated QA checkpoints and risk-based batch classification.
CAPA & Deviation Management
- Directed investigations of deviations, OOS/OOT results, and change controls; reduced CAPA cycle time by 30% using risk-based prioritization and digital workflows aligned with ALCOA+ principles.
Validation & Lab Oversight
- Oversaw analytical and microbiological validation for high-potency products; directed qualification of over 12 QC instruments under CAPEX plans, redesigning sampling workflows and doubling microbiological throughput.
QMS Implementation & Digital Transformation
- Led QMS deployment and document control systems across all departments; spearheaded SAP HANA and ATTP rollouts, ensuring serialization, data integrity, and digital batch record compliance.
GMP Audits & Inspections
- Conducted routine GMP inspections of production, packaging, and cleanroom areas; enforced corrective actions and led internal audit programs aligned with Annex 1 requirements.
Strategic Supplier & CMO Oversight
- Assessed and enhanced quality systems of third-party manufacturers and raw material vendors; extended QA support to subsidiaries and international partners.
Team Leadership & Cross-Functional Collaboration
- Built and led QA teams across multiple functions and seniority levels, fostering collaboration with manufacturing, engineering, and regulatory teams for integrated quality execution.
REF · GB-03 / FIVE RIVERS HEALTH CENTERS
Member, Board of Directors
Five Rivers Health Centers Inc., Dayton, Ohio, USA
2014 — 2016 · 2 YEARS
- Provided strategic direction and governance for a federally qualified health center network, contributing to policy development and regulatory alignment with U.S. healthcare quality standards.
- Reviewed clinical quality indicators, accreditation status, and regulatory compliance; advocated for initiatives enhancing patient care access, safety, and service equity.
REF · ED-02 / ACADEMIA GATE
Executive Director & Social Media Consultant
Academia Gate, Dayton, Ohio, USA
2015 — 2017 · 2 YEARS
- Directed organizational operations and digital strategy for a U.S.-based academic services platform, overseeing project planning, stakeholder engagement, and resource allocation.
- Designed and executed data-driven social media campaigns using SEO and analytics tools to increase academic program reach and digital presence.
REF · MR-01 / ZAD INDUSTRIAL PHARMA
Medical Representative
ZAD Industrial Pharma, Cairo, Egypt
2011
- Promoted pharmaceutical products to healthcare professionals, achieving territory sales targets and expanding the prescriber base through clinical, evidence-based detailing.
- Built and maintained relationships with key physicians and pharmacists, providing regular market feedback and competitor insights.
REF · CP-01 / AL-ASHRY PHARMACY
Community Pharmacist
Al-Ashry Pharmacy, Cairo, Egypt
2009 — 2010
- Dispensed prescription medications with a focus on dosage accuracy and patient education; advised on drug interactions and adherence.
- Managed stock levels and ensured compliance with local pharmacy laws and regulatory standards.
REF · CP-00 / EL EZABY PHARMACY
Community Pharmacist
El Ezaby Pharmacy, Cairo, Egypt
2009
- Delivered over-the-counter medication advice and basic health consultation, supporting chronic disease patients with dosing and therapy follow-up.
- Maintained accurate records and product availability in one of Cairo's busiest pharmacy chains.
03
Education
MS, Pharmaceutical Manufacturing
Stevens Institute of Technology
NJ, United States
2024 – 2026
MBA, Business Administration
University of Dayton
Ohio, United States
2013 – 2014
BS, Pharmaceutical Sciences
Ain Shams University
Cairo, Egypt
2006 – 2012
04
Skills & Languages
Core Technical
Leadership
Software & Digital Tools
Languages
05
Certifications, Workshops & Training
Regulatory & QP Credentials
Licensed Quality Responsible Person (QP)SFDA, 2019
Qualified Technical Manager & Qualified PersonMesned Pharma, 2022
QP Training WorkshopAgon Training, 2021
GMP, Validation & Risk-Based Quality
Certified Quality Manager (CQM)UHRDA, 2021
Manager of Quality / Organizational ExcellenceASQ, 2021
cGMP Compliance, Inspection & Remote Audits2021
Risk-Based Approach for CQVPharMatrix KSA, 2021
Foundations of GMPUSP, 2021
Cleaning Validation GuidelinesECOLAB, 2021
ISO & Quality Management Systems
ISO 9001:2015 Lead AuditorTUV
IMS Certificate — ISO 9000, 14000, 45001TUV
Integrated Management System AwarenessTUV, 2019
Integrated Management System AuditingTUV, 2018
Specialized & Academic Training
Introduction to Pharmaceutical PackagingManagement Forum, 2018
Total Quality Management WorkshopU. of Dayton, 2013
Quality Management WorkshopU. of Dayton, 2013
06
Affiliations & Professional Recognition
Regulatory Roles
09/2025 — Present
Qualified Person (QP)
Site Quality Responsible, SpectroPharma, Riyadh
2019 – 09/2025
Qualified Person (QP)
Plant Registered License, SPIMACO Addwaeih, Buraydah
2024 — Present
Consultant & Committee Member
Saudi Commission for Health Specialties (SCFHS), Riyadh
2019 — Present
Member
Saudi Pharmaceutical Society
Professional Memberships
- Quality Ambassador — SASO, 2021
- Member — International Pharmaceutical Federation (FIP)
- Member — Saudi Pharmaceutical Association (SPhA)
- Member — European Compliance Academy (ECA), GDP Group
- Member — International Society for Pharmaceutical Engineering (ISPE)
- Member — American Society for Quality (ASQ)
- Young Professional Member — Parenteral Drug Association (PDA)
- Member — European Qualified Person (QP) Association
- Member — American Association of Pharmaceutical Scientists (AAPS)