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Open nowPosted 3 days ago

GMP Readiness Lead

EURES job mobility portal576,476 open roles

Where
Agglomeratie ’s-Gravenhage, Netherlands
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Your applicationOpen nowGMP Readiness LeadEURES job mobility portal · Agglomeratie ’s-Gravenhage, Netherlands
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The clock on this job

Early applications get read.

10.5% of postings close within 7 days. Measured by our own scanner across the market. EURES job mobility portal postings stay open a median of 9 days.

Share of postings closed within
  1. 2.1%1 day
  2. 4.3%3 days
  3. 10.5%7 days
  4. 15.9%14 days
  5. 34.1%30 days
This job: posted 3 days ago

EURES job mobility portal median: 9 days open

The posting

GMP Readiness Lead - Noord-Holland - 5000.00 - 8000.00 - 40 uren - Project vanaf een jaar - HBO Opdrachtgever Onze opdrachtgever biedt consultancy- en engineeringondersteuning voor veeleisende, multidisciplinaire projecten in de biotech- en life sciences-sector. Opdrachtgever Onze opdrachtgever biedt consultancy- en engineeringondersteuning voor veeleisende, multidisciplinaire projecten in de biotech- en life sciences-sector. Hun reputatie is gebaseerd op het aangaan van succesvolle samenwerkingsverbanden met klanten, waarbij zij innovatieve ontwerpen en kosteneffectieve oplossingen leveren, gestoeld op een gedegen oordeelsvorming, sterk management en technische uitmuntendheid. functie Vereisten Must-have - Minimaal 15 jaar ervaring binnen GMP-gereguleerde farmaceutische- of biotech-omgevingen. - Aantoonbare ervaring met het verkrijgen van een eerste GMP-licentie of het operationeel gereed maken van nieuwe productiefaciliteiten. - Diepgaande kennis van EU GMP, ICH-richtlijnen, FDA cGMP, Pharmaceutical Quality Systems. - Sterke ervaring met validatie-, kwalificatie- en inspectietrajecten. - Ervaring in een senior programma-, project- of transformatieleiderschapsrol. - Sterk stakeholdermanagement op directie-, project- en operationeel niveau. - Uitstekende beheersing van Nederlands en Engels. Sterke pre - Ervaring met radiopharmaceuticals, radionucliden of nucleair gereguleerde omgevingen. - Ervaring met API-productie en/of productregistraties. - Bekendheid met EMA-, FDA- en internationale inspecties. - Ervaring binnen greenfield of first-of-a-kind productiefaciliteiten. Persoonlijke kenmerken - Strategisch sterk en tegelijkertijd hands-on. - Resultaatgericht met focus op licentie- en inspectiegereedheid. - Besluitvaardig en in staat tegengestelde belangen te verbinden. - Een natuurlijke leider die multidisciplinaire teams kan aligneren op GMP-doelstellingen. - Sterk in risicoanalyse, prioritering en executie. Wat k...

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