KEY TO QUALITY
KEY TO COMPLIANCE
KEY TO SUCCESSFUL FILING
KEY TO PEOPLE DEVELOPMENT
Ilse Nelissen
Consultant - Founder of KEYGCP Services
Functieomschrijving
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Functieomschrijving
Beschrijf de mensen die bijdragen aan de website en uw idee. Uw bezoekers zullen het op prijs stellen meer over u te weten.
Functieomschrijving
Beschrijf de mensen die bijdragen aan de website en uw idee. Uw bezoekers zullen het op prijs stellen meer over u te weten.
An experienced leader in GCP Quality, Compliance, Training and Clinical Operations for >25 years within the Pharma Industry and at/with CROs.
Patients, People and Science have always been my passion and have been driving my career path to where I am today.
I truly enjoy auditing and managing key Health Authority inspections across therapeutic areas at sponsor-, investigator site-, as well as vendor locations across the globe.
Managing and leading teams (directly and indirectly) throughout these activities while training, coaching them along the way has been a natural and fulfilling task.
Another rewarding and enriching opportunity in my career was to hire, train and lead GC(L)P auditors in China and Belgium while building the AsiaPac Clinical Trial Strategy with the Key Stakeholders.
Applying risk-based and end-to-end thinking during the approximately 200 audits and inspections I performed and managed resulted in many Research and Development and Quality Assurance process improvements.
I am a loyal, results driven, hardworking leader while always curious and open for challenges, leading me to the ultimate challenge of starting-up my own company.
llse can coordinate complex projects and engage stakeholders across departments to make the project successful. She successfully led the entire audit program globally for one of our major compounds across indications and regions. This program also involved a partnership with an alliance partner and was outsourced, which required skillful communication and relationship building.
As an auditor, Ilse has the capacity to see issues from a helicopter view, connecting the dots beyond departmental boundaries. She is able to identify the gaps in the process, but also in advising potential action plans to remediate the issue. She led key EMA inspections to successful outcome, because of her ability to approach complex issues in a systematic and organized manner, involving the right stakeholders at the right time.
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