Quality Assurance Regulatory Affairs Manager

A growing international biopharma/biotech manufacturer is establishing operations in the Eastern Province of Saudi Arabia and is looking for a Quality & Regulatory Affairs Manager to lead its Quality and RA functions at country level. This is a senior, high-autonomy role and the single point of accountability for Quality (QA, QC, validation, audits, biosafety) and Regulatory Affairs as the site is built up and licensed.If you've led quality and regulatory at a pharma/biotech manufacturing site and want to shape a function from the ground up, this is a rare opportunity.What you'll do• Own the Quality Management System (QA, QC, validation, audits, GMP) and align it with corporate and international standards• Define and drive the regulatory strategy — product registrations, plant licensing, and manufacturing authorization• Act as the primary interface with regulatory authorities and lead inspection readiness• Lead technology transfer from a quality and regulatory standpoint, from validation strategy through facility readiness• Oversee product quality, data integrity, stability programs, and the biorisk/biosafety management system• Build and lead the Quality & RA teamWhat you'll bring• Life Sciences degree (MSc/PhD preferred)• 10+ years in biopharma/biotech, including 7+ years in Quality leadership roles• Hands-on experience at a pharmaceutical/biotech manufacturing site (not office-only RA)• Proven track record with regulatory agencies, submissions, inspections, and product approvals — experience with SFDA / GCC authorities is a strong advantage• Fluency in both Arabic and English (written and verbal) is required• This role falls under Saudization; Saudi nationals are strongly encouraged to applyLocation: Eastern Province, Saudi Arabia (on-site)Employment type: Full-time, permanent