Identify improvement opportunities that can increase the IVD product development quality and efficiency in accordance with FDA, EU-IVDR and international regulations. IVD product means platform, assay and software. The span of the development process in scope will include hand over from phase 0 to development as well as hand over from development to make and sell for product launch. It covers both internal and outsourced developed products.
Knowledge gaps with the teams (inc. project managers) in the IVD development trajectory.
Knowledge gaps with the teams (inc. technical leads) on how to make robust IVD designs and ensure traceable and consistent reporting throughout the corresponding documentation.
Limited repeatability in the overall design and development process, inc. design choices, documentation, validation protocols, limited cross-project use of data and information, ...
Insufficient clarity on some roles and responsibilities.
Organisational improvement opportunities.
Behavioral improvement opportunities related to design control compliance with FDA and other international regulations.
Provide hands-on guidance to the teams to implement the identified improvements:
Provide support to process owners to write procedures, work instructions and templates to clearly outline all phases and steps of the development process in a standardized way.
Provide hands-on training sessions to the relevant teams on the improvement actions and arrange for proper follow-up and monitoring of the implementation of the identified improvement actions.
Provide hands-on guidance on introducing repeatability into our design and development process, including the use of assay building blocks, re-use of documentations and protocols, recycling of data and information across projects, ...
Provide recommendations on organisational improvements and guide the teams during the transition process.
Identify clear process owners for each step of the development process. Clarify the roles and responsibilities, and ensure all people involved fully understand it.
PhD in in pharmaceutical, biomedical, (bio)chemical or biological sciences, or equivalent by training. Preferably in molecular biology.
At least 7 years industrial experience with IVD development, preferably IVDs in the area of molecular diagnostics.
At least 5 years industrial experience with analytical and clinical validation of IVDs.
At least 5 years industrial experience with working under FDA and EU regulated design control.
Strong knowledge of international regulatory standards (ISO, CLSI, FDA).
Knowledge of ISO13485 is a must.
Process improvement thinking.
Strong educational skills to clarify and translate specific regulations, recommendations and standards into SOPs that can be executed by the teams.
Strong communication skills to provide training to a large audience of people with various levels of education.
Strong knowledge of the technologies used in molecular diagnostics, and the pitfalls that may lay in the design of an assay.
Industrial experience with FDA submissions of molecular diagnostics is a strong plus.
Change management skills.
Practical and positive thinking.
Affinity with statistics is a plus.
Excellent operational excellence mindset.
Excellent interpersonal and team working skills.
Excellent technical writing and documentation skills.
Excellent educational skills.
Collaborative problem solver, handles conflict constructively.
Business acumen (practical thinking and solution-minded).
Well-developed organizational, planning and prioritization skills
Able to work under pressure and have a flexible approach.
Fluent in English, written and spoken.