Martin Dupressoir, PharmD, MSc.
Senior Pharmaceutical Quality Professional specialised in Quality Management and Quality support
for Clinical and Pharmaceutical
Development Teams.
With 10 years of experience in various quality role, including 7 years in RLT and Theranostics development, I am looking forward to help you build, update, and review your processes and practices.
Lead Quality functions and cross-functional teams in an international and remote-first environment,
Define tailored Quality strategy based on the company’s objectives, challenges, and expected Cost-of-Quality and Cost-of-Non-Quality balance,
Design, Implement, and Maintain Quality Management Systems in compliance with EuGMP, cGMP, GCP and other key regulations,
Transform the QMS in a performance enhancer for operations and support teams: Make your Quality System and investment,
Incorporate Risk-Management and Knowledge-Management in all aspects of the QMS, reinforce the Process approach as key lever for Quality culture.
Support Clinical Development activities with expertise in Study Management, clinical Risk Management, and general Study Quality oversight as understood in ICH E6,
Support Pharmaceutical Development activities with extensive knowledge in manufacturing, analytical, and distribution development and validation,
Define and support execution of phase-appropriate validation/confirmation strategies,
Anticipate potential Risks associated with development activities and provide adequate mitigation strategies,
Oversee quality of Investigational products, with complex supply-chains and time or ressource constraints,
Communicate clearly with colleagues, cross-functional team members, and senior-management.
Support selection of key and critical vendors with quality concerns and preliminary evaluation,
Define flexible risk-based approach to Vendor Qualification,
Define annual Audit plans, advise on make-or-buy decision,
Execute remote, desktop, and on-site vendor audits,
Define and follow-up KPIs with vendor to track performance and act preemptively.
Worked extensively with 68Ga, 18F, 177Lu, and 225Ac,
Implemented complex supply-chain including virtual pharmaceutical importation in the EU,
Oversaw 150+ administration of various radiopharmaceuticals (diagnostics and therapeutics),
Supported successful submission of novel alpha-therapy in oncology for both the USA and UK,
Contributed to the development of kits, central-manufactured hot-products, ancilliaries, etc.,
Prepared and QCed various SPECT preparations (111In and 99mTc).