Deyaa Shaheen

Senior Consultant, GxPAssure

Deyaa Shaheen is a transformational Quality and Compliance leader with more than 25 years of global experience spanning pharmaceutical, biopharmaceutical, sterile, biologics, and nutraceutical operations. A former FDA Drug Investigator, he has conducted over 50 pre‑approval and surveillance inspections across APIs, finished dosage forms, OTC products, generics, sterile manufacturing, and biologics—three of which resulted in nationally significant FDA Warning Letters.

Recognised as a Data Integrity Subject Matter Expert, Deyaa has delivered more than 250 mock audits for manufacturers, CMOs, and contract laboratories worldwide. His technical range extends across CGMP compliance, inspection readiness, remediation strategy, and organisational quality culture transformation. He brings hands-on expertise in analytical testing, including KF, HPLC, UPLC, FTIR, GC, and ICPMS, and provides senior level oversight of OOS/OOT investigations and quality systems optimisation.

Deyaa is widely known within the industry as a regulatory liaison to the FDA and global health authorities, advising senior leadership teams on complex compliance challenges and guiding successful remediation programmes built on robust, risk-based quality frameworks. He is also a multilingual communicator and respected industry speaker, frequently presenting on CGMP, data integrity, inspection readiness, and quality systems.

In 2020, he received Group Recognition at the FDA’s 60th Annual Honor Awards for his leadership in delivering the FDA’s “Concept of Operations,” a cross-centre initiative designed to enhance regulatory oversight and improve the agency’s management of pharmaceutical complexity.

His core areas of expertise include:

• CGMP compliance and global regulatory expectations (FDA, EMA, MHRA, Health Canada, ICH, USP)
• Inspection readiness for surveillance, PAI, for cause, and clinical phase inspections
• Enterprise data integrity implementation across manufacturing, QC, and laboratories
• Mock audit execution and audit programme leadership (250+ audits)
• CAPA strategy, risk management, and remediation programme delivery
• Quality systems design (QMS, SOP governance, change control, RACI models, QIPs)
• Analytical testing leadership (HPLC, UPLC, FTIR, GC, ICP‑MS, KF)
• Technical writing for regulatory submissions and communications (CRLs, memos, responses, reports)