Fatemeh Ahmadraji

Quality Management Professional with 9+ years in biopharma and small molecule sectors. Expert in QMS design, CMO qualification/oversight, and GxP compliance. Skilled in production quality, change control, deviations, audits, and vendor qualification. Proven record in leading international projects and ensuring EU/FDA/global standards. Strong leadership in QA, cross-functional teamwork, and consulting on quality systems and GxP

Established and led QMS aligned with ISO and regulatory guidelines; trained staff and mentored QA team. Led audits for supplier qualification and managed documentation, SOPs, and quality manuals. Oversaw change control, investigations, and risk management (FMEA). Provided QA support for regulatory inspections and ensured compliance. Managed vendor oversight and collaborated closely with CMOs.

Led internal/external audits, vendor qualification, CAPA follow-up, and batch record release. Key audit team member for Sanofi, Roche, Novartis. Managed quality agreements, QMS, and supervised QA/RA teams. Handled deviations, CAPAs, change control, lab investigations, complaints, and quality risks. Collaborated with Supply Chain, Marketing, and Purchasing. Reviewed/approved qualification docs and contributed to Product Quality Reviews.

Developed SOPs and quality standards, audited suppliers, and ensured vendor oversight. Acted as key contact for supplier quality issues. Investigated deviations and OOS, assessed CAPA effectiveness, and managed change control and quality risk per ICH Q9. Reviewed batch records and analytical method validations. Managed supplier contracts and was a key member of the Product Quality Review team and ISO 9001 certification efforts.