About Retzlaff Consulting Inc.
Where global GMP expertise meets purpose-driven quality leadership.
Founded by Dr. Marco Retzlaff, Retzlaff Consulting Inc. delivers senior, inspection-facing GMP and Quality leadership to life science organizations at critical inflection points. With over 15 years of international experience across Europe and North America, Marco has led quality initiatives spanning global generics and biosimilars to advanced biologics and clinical-stage biotech.
Most recently, at AbCellera Biologics, Marco built and led the phase-appropriate GMP quality infrastructure supporting the transition from R&D to clinical manufacturing, including GMP facility readiness and CQV oversight for a new ~130,000 sq. ft. GMP facility under accelerated timelines.
His leadership includes:
GMP facility readiness & CQV oversight, integrating quality into facility design, start-up, and first GMP operations
Fractional and executive QA leadership, including Head of QA Operations and interim CQA roles
EU GMP/GDP certification and license oversight, maintaining compliant manufacturing, importation, and distribution operations across multiple EU affiliates
EU QP release and commercial batch disposition (>5,000 batches/year) for Novartis/Sandoz
Inspection readiness and remediation, engaging FDA, EMA, Health Canada, Swissmedic, AGES, ANVISA, and other authorities
Global development QA oversight, enabling network-wide product realization across multiple modalities
Previously, Marco served as Head of QA Operations for Novartis / Sandoz in Germany, led an EU QP Release Hub, and acted as Wholesaler Responsible Person and Narcotics Officer. Earlier roles at Accord Healthcare and Sandoz International included global development QA leadership and remediation of complex GMP environments.
With a PhD in Biotechnology, Lean Six Sigma Green Belt certification, and training as a European patent attorney, Marco brings a rare combination of scientific depth, regulatory rigor, and business-aligned execution. At the core of his work is a commitment to quality culture—empowering teams to make sound decisions and embed compliance into daily operations.
