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Yacine Coura Niang
Is a senior pharmaceutical quality professional with more than 15 years of experience gained within highly regulated environments across Canada and Europe. Her expertise spans multiple stages of the pharmaceutical product lifecycle, including active pharmaceutical ingredients (APIs), pharmaceutical products, biologics, biotechnology, and cell and gene therapies.
Holding an MSc. degree in biotechnological drug development, complemented by Master in management obtained in France and a specialization in quality in Pharmaceuticals at Montreal, she combines scientific expertise, quality leadership, and a deep understanding of the regulatory requirements applicable to the pharmaceutical industry.
Throughout her career, she has held positions of increasing responsibility in Quality Assurance and Quality Management. Her areas of expertise include Quality Management Systems (QMS), GMP compliance, regulatory inspections, internal, client, and supplier audits, Quality Risk Management (QRM), investigations and CAPA, supplier qualification and oversight, Data Integrity, and continuous improvement.
Practical Experience with Regulatory Inspections
Yacine has served as both host and Quality representative during several regulatory inspections conducted by Health Canada and the U.S. Food and Drug Administration (FDA). She has contributed to inspection readiness activities, coordinated inspection-related operations, acted as the primary interface with inspectors, and supported the management of observations and post-inspection action plans.
This experience has provided her with a practical understanding of inspection readiness. Beyond document preparation, she helps organizations build a quality culture in which systems, teams, and operational practices are continuously prepared to demonstrate a state of control.
She has also led and supported client and supplier audits, supplier qualification and monitoring programs, as well as major quality system transformation initiatives.
Her achievements include the complete redesign of the quality system for Quebec’s leading generic pharmaceutical manufacturer, including the optimization of the documentation structure and key quality processes.
Today, her experience in the field of cell and gene therapies further enriches a career built across multiple pharmaceutical and biotechnology platforms, strengthening her expertise in risk management, compliance, and regulatory inspection readiness.
From Quebec to Senegal: Expertise in Service of Excellence
Yacine Coura Niang founded YCN Consulting with a strong conviction: quality should not be viewed solely as a regulatory obligation.
An effective quality system must protect patients, control risks, support operations, and create the conditions for sustainable performance.
Bridging Quebec and Senegal, YCN Consulting leverages expertise gained in international regulated environments to support pharmaceutical and biotechnology companies, healthcare organizations, and businesses committed to quality and operational excellence.
Its mission is to assist organizations in building, evaluating, and continuously improving robust, pragmatic quality systems tailored to their level of maturity, while preparing them to meet regulatory requirements and international standards applicable to their activities.
15+ YEARS
Pharmaceutical & Life Sciences Quality
REGULATORY INSPECTIONS
FDA • Health Canada • Inspection Readiness
QUALITY LEADERSHIP
QMS • GMP • CAPA • Auditing • Risk Management • Supplier Quality
INDUSTRY DIVERSITY
API • Pharmaceuticals • Biologics • Cell & Gene Therapy
INTERNATIONAL EXPERIENCE
Canada • Europe • Africa
Our Mission & Vision
To strengthen organizations through practical, risk-based and sustainable Quality & Compliance solutions.
YCN Consulting brings international expertise and real-world industry experience to help organizations build robust Quality systems, strengthen regulatory compliance, manage risk and develop the capabilities needed to achieve sustainable operational excellence.
To contribute to a future where Quality is a driver of trust, performance and sustainable growth.
Our vision is to bridge international standards with local realities, empowering organizations, particularly in Senegal and across Africa, to build strong Quality cultures, meet evolving regulatory expectations and compete confidently on the global stage.
International experience & Global Quality Standards
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North America & Europe
Francophone West Africa
Regulatory Standards
Global Quality Perspective
More than 15 years of Quality experience across pharmaceutical and life sciences organizations in Canada and Europe, bringing established industry practices and international perspectives to every engagement.
Supporting organizations in Senegal and Francophone West Africa in strengthening Quality systems, building capabilities and aligning their operations with applicable international standards and regulatory expectations.
Practical expertise in GMP, Quality Management Systems, Quality Risk Management and regulatory inspection readiness, supported by direct experience hosting multiple Health Canada and FDA inspections.
Combining international Quality practices with a pragmatic understanding of local operational realities to deliver solutions that are compliant, sustainable and adapted to each organization.