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Director Commercial Quality assurance Compliance

N/A, Netherlands | Incyte Corporation

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
    Full-Time
  • Functions:
    General Management
  • Experience:
    10-12 years
Job Description:
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Summary


The Director Commercial QA Compliance EUQP, will Manage the Incyte Netherlands Quality Organization in charge of Commercial and IMP products importation, release for EU/EEA markets as well as wholesale distribution to EU countries. 


He/She will lead the maintenance of the site Quality Management System and will act as the lead EUQP to perform Commercial Product batch certification. 


He/She will manage another EU QP. 


He/She will belong to the Global Commercial QA Organization and will ensure the GMP compliance of Commercial GMP activities. 


Key Responsibilities 


Incyte Netherlands Quality Management System:


Establishment and maintenance of the Incyte Netherlands Quality Management System covering both Commercial product and IMP activities


Manage another EU QP


Ensure Incyte Biosciences Distribution Inspection readiness;


Maintain Incyte Netherlands GMP/GDP regulatory licenses


Interact with Dutch and European Authorities as it pertains to the Incyte Netherlands Licenses and GMP/GDP activities;


Act as Contact Person for Product Defects and Recall for EMA


Support Recall of medicinal products when needed;


EU/EEA Qualified Person responsibilities:


Batch release and certification of commercial products in the EU in accordance with EU GMP Annex 16;


Provides QP GMP declarations in support of regulatory fillings;


QP review and evaluation of deviation, complaints, change controls, PQRs


Perform QP audits;


Establish QP to QP agreements when required;


Decide on the final disposition of returned, recalled or falsified products;


Be continuously contactable.


Act as back-up of Incyte Netherlands IMP QP


GMP/GDP compliance:


Establish and maintain a regulatory compliance watch process (GMP/GDP) to ensure that the organization meets current regulatory requirements;


Assure New Product Introductions compliance for EU market


Perform internal and external audits


Implement GMP Inspection Readiness Programs for commercial GMP/GDP sites


Monitor the compliance status of commercial QA activities through of the Establish and maintain compliance dashboard process (GMD/GDP) to monitor the compliance level of the Organization


Ensure Global Quality Plan is executed according to plan for commercial GMP activities. 


Requirements 


Doctorate or Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering);


At least 10 years experience in QA for international pharmaceutical industry with at least 5 years experience as QP


Eligible to be registered as EU QP in Netherlands


Experience in release of commercial Product of different pharmaceuticals forms. Experience with biotech/sterile products is an asset


Preferred experience with release of IMP


Thorough knowledge in cGMP and global regulatory requirements (US, EU, JP, CH);


Sound awareness and understanding of pharmaceutical and biotech business;


Solid experience in team management;


Strong problem solving skills;


Excellent verbal and written communication skills with well-structured communication and presentation ability;


Results focused which may require negotiating skills, empathy, diplomacy, common sense


Team player and ability to work with remote teams


English fluency written and spoken (the company language);


Travel up to 25% 


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