Iris Shamir | M.Sc.

VP, Quality Assurance – Pharma

Pharmaceutical Quality and Regulatory Executive with more than 25 years of experience in Quality Assurance, Compliance, Quality Control and Regulatory Affairs across the pharmaceutical, biotechnology and medical device industries.

Former GMP Inspector at the Israeli Ministry of Health with extensive experience in manufacturing oversight, regulatory inspections and quality system transformation.

Specialized in GMP, GxP, FDA and EU regulatory requirements, laboratory compliance, data integrity, risk management, cleaning validation, cross-contamination prevention, quality investigations and inspection readiness. Proven track record of leading organizations through successful regulatory inspections and complex quality transformation initiatives.

Iris holds a B.Sc., from the Technion, Haifa – in Food engineering and biotechnology, and an M.Sc. with honors from the Hebrew University, Faculty of Agriculture – Rehovot; Department of Biochemistry and Human Nutrition.

Throughout her career, Iris has held senior leadership positions at Teva Pharmaceutical Industries, Dexcel Ltd., Q Medical Devices and the Israeli Ministry of Health, leading quality organizations across pharmaceutical manufacturing, sterile products, inhalation products and combination products. Today, Iris supports pharmaceutical, biotechnology and medical technology companies in building and improving quality systems, preparing for regulatory inspections, conducting audits and gap assessments, managing compliance remediation programs and implementing practical, risk-based quality solutions.

Her experience includes FDA inspection readiness, EU GMP compliance, laboratory auditing, supplier qualification and quality culture development.

Iris is passionate about helping organizations achieve sustainable compliance while maintaining operational excellence