Head of Quality Assurance

* Architect and implement robust Quality Management Systems (QMS) that meet DGDA and international standards, including WHO, PICs, EU, US-FDA, ISO 13485, and MDR for medical devices. * Drive quality and regulatory compliance for pharmaceuticals, biosimilars, and medical devices, ensuring all products meet stringent requirements prior to release. * Manage product registration and regulatory submissions, overseeing the entire process to guarantee timely and accurate submissions. * Lead cross-functional teams through internal and external audits, including regulatory inspections, to ensure seamless compliance and minimal risk. * Develop and maintain control over documentation, deviations, CAPA, change control, and risk management processes, ensuring data integrity and compliance. * Collaborate with production, engineering, QC, and R&D teams to integrate quality compliance into all aspects of product development and manufacturing. * Design, review, and refine batch manufacturing documents, SOPs, validation protocols, and reports to ensure accuracy and compliance. * Oversee quality control activities, including environmental monitoring, stability studies, validation and qualification, calibration, and preventive maintenance, to guarantee product quality and safety. * Develop and deliver training programs to enhance employee knowledge and skills, driving a culture of quality and compliance throughout the organization.