Mahnaz Yazdani

PMP-certified Project Management Professional with a PhD in Biochemistry and over seven years of experience leading cross-functional initiatives within pharmaceutical and biopharmaceutical environments. Proven success managing quality, compliance, and operational projects while collaborating with Quality Assurance, Quality Control, Manufacturing, Technical Services, Regulatory Affairs, and clients to achieve business objectives. Skilled in project planning, stakeholder engagement, risk management, change control, process improvement, and regulatory compliance under Health Canada and FDA GMP requirements.

Recognized for driving continuous improvement initiatives, coordinating multidisciplinary teams, solving complex problems, and delivering high-quality outcomes in fast-paced, highly regulated environments.

Quality Assurance Document Reviewer - Thermo Fisher Scientific - Whitby, Ontario

(2021-04)

• Coordinate quality-related activities across QA, QC, Manufacturing, Technical Services, and client teams to support timely project execution and product release.
• Lead end-to-end review of GMP manufacturing documentation and analytical data to ensure compliance with regulatory requirements and project timelines.
• Manage multiple concurrent priorities while maintaining high accuracy and meeting business deadlines.
• Lead and facilitate deviation, CAPA, and investigation activities by coordinating stakeholders, identifying root causes, assessing risks, and implementing corrective actions.
• Participate in change control initiatives by evaluating project impacts, supporting implementation, and ensuring compliance throughout the project lifecycle.
• Drive continuous improvement projects that increase operational efficiency, improve document review processes, and reduce compliance risks.
• Monitor project progress, identify risks, develop mitigation strategies, and communicate updates to management and cross-functional teams.
• Support internal, client, and regulatory audits by coordinating documentation, tracking action items, and ensuring inspection readiness.
• Mentor new team members on project workflows, GMP requirements, quality systems, and best practices.
• Maintain project documentation and quality records in accordance with GMP requirements and ALCOA+ data integrity principles.

PhD - Biochemistry - Tarbiat Modares University

MSc - Biochemistry - Tarbiat Modares University

BSc - Biology - Shiraz University

Diploma - Research & Development of Drugs - TIPT