Marlous van der Hooft

Marlous brings more than two decades of experience in radiopharmaceutical manufacturing, operations, quality, supply chains and organisational leadership. Her career began in microbiology and laboratory work, where she learned how technical detail, reliable processes and sound professional judgement affect real outcomes.

From there, she moved into radiopharmaceutical manufacturing and the implementation of new facilities, later taking responsibility for international manufacturing networks, contract manufacturers, global supply chains and site operations.

These experiences shaped the approach behind Qualificiency: compliance and operational performance should strengthen one another, and solutions should be designed around how work actually happens.

From Laboratory Work to Radiopharmaceutical Manufacturing

With a background in microbiology and medical biology, Marlous began her professional life in hospital and pharmaceutical laboratories, working in microbiology, quality control and validation.

She subsequently helped establish FDG production in Eindhoven and spent several years implementing PET manufacturing sites across Europe. Her work included manufacturing and facility requirements, qualification, validation, technology transfer, training and preparation for routine operations.

In total, she managed or supported the design, construction, qualification and start-up of 13 PET manufacturing sites. Working at the interface between users, engineers, quality specialists and operational teams taught her how decisions made during design affect years of everyday performance.

Manufacturing Networks and Reactor-Isotope Supply Chains

Marlous went on to lead manufacturing and supply-chain activities across PET consumables and international contract-manufacturing networks. This included product introductions, supplier and CMO relationships, production planning and manufacturing transfers.

At GE HealthCare, she was operationally responsible for transferring Tc-99m generator manufacturing from The Grove Centre to Curium as a contract manufacturing organisation. Her responsibilities included coordinating Mo-99 availability and supply planning, isotope deliveries to the manufacturer, and the interfaces required to supply finished generators to customers.

Her responsibilities also covered I-131 radiopharmaceuticals, including MIBG products, with supply planning and coordination across isotope production, radiopharmaceutical manufacturing and finished-product supply.

This gave her first-hand experience of how reactor-isotope availability, production capacity, quality requirements, logistics and customer demand affect each other — and how difficult supply decisions can become when patient needs depend on material that is simply not available in sufficient quantities.

Leading Operations and Making Systems Work

As Site Operations Manager and later Site Leader in Braunschweig, Marlous took responsibility for manufacturing, engineering, supply planning, logistics, safety, operational performance and the people connecting these functions.

Her work combined site leadership with Lean and Six Sigma, quality culture, process improvement and practical decisions about investment, technical capability and delivery reliability.

She has seen that an individual procedure can be compliant while the process as a whole remains unnecessarily complicated or unreliable. For her, efficiency is not about rushing: it is about removing avoidable barriers so that people can consistently do the right thing.

Connecting Technical Design, Compliance and People

Later, while establishing and leading a radiopharmaceutical engineering and consulting business in Germany, Marlous worked from the user perspective on facility concepts, GMP expectations, contamination control and the practical implications of engineering decisions.

She founded Qualificiency as an independent consultancy in 2025. As its work and team developed, Qualificiency grew into a broader organisation bringing together complementary experience in operations, quality, validation, regulatory matters and logistics.

Her approach centres on the interfaces: between suppliers and customers, engineering and manufacturing, Quality and Operations, regulatory requirements and the people expected to work with them. She believes that good solutions emerge when those perspectives understand one another.

What Marlous Brings to Qualificiency

At Qualificiency, Marlous combines operational leadership, radiopharmaceutical manufacturing, supply-chain management, GMP, qualification and validation, and user-side design experience.

She helps teams understand the reasons behind requirements, identify the risks that matter and develop controls and processes that remain workable in routine operation. Knowledge transfer and professional judgement are as important to her as the immediate project deliverable.

Her guiding idea is simple: compliance is essential, but it should be designed into processes that work — not added as complexity after the fact.