Director Commercial QA Compliance, EU/EEA Qualified Person

Director Commercial QA Compliance, EU/EEA Qualified Person

Incyte

Netherlands

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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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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