Quality Assurance Regulatory Affairs Manager

Job Overview

An expanding international biopharma and biotech manufacturer is initiating operations in Saudi Arabia's Eastern Province and is seeking a dedicated Quality & Regulatory Affairs Manager. This senior role carries a high level of autonomy and accountability for overseeing the Quality (Quality Assurance, Quality Control, validation, audits, biosafety) and Regulatory Affairs functions at the country level, particularly as the production site is developed and licensed.

Key Responsibilities

• Manage and maintain the Quality Management System encompassing QA, QC, validation, audits, and GMP compliance, ensuring alignment with both corporate policies and international regulatory standards.
• Develop and implement regulatory strategies including product registrations, plant licensing, and obtaining manufacturing authorizations.
• Serve as the primary point of contact with regulatory authorities and prepare the site for inspections.
• Lead technology transfer processes focusing on quality and regulatory compliance, from validation planning to facility readiness.
• Supervise product quality assurance, data integrity measures, stability studies, and the biorisk/biosafety management program.
• Establish and manage the Quality & Regulatory Affairs team, fostering a compliant and efficient work environment.

Candidate Profile

• Possess a Life Sciences degree, preferably an MSc or PhD.
• Accumulate over 10 years of experience in the biopharma or biotech sector, with at least 7 years in quality leadership positions.
• Demonstrate practical experience at a pharmaceutical or biotech manufacturing facility, beyond office-based regulatory roles.
• Have a proven track record handling regulatory authority submissions, inspections, and product approvals, with knowledge of SFDA and GCC regulatory frameworks considered a strong asset.
• Be fluent in Arabic and English, both spoken and written.

Additional Information

• This position is based onsite in the Eastern Province of Saudi Arabia.
• The employment is full-time and permanent.
• The role is subject to Saudization policies; Saudi nationals are highly encouraged to apply.