The Drive to Discover. The Experience to Deliver.

Careers At Incyte Corporation

Looking for a challenge and a chance to grow your career?

Then Incyte is the pharmaceutical company for you. While our pipeline demonstrates the ability to compete with much larger pharmaceutical companies in selecting compelling targets and creating high-quality drug candidates, our smaller size enables employees to see the direct impact of their contributions on the direction of the company. Due to our smart, agile culture and cutting-edge science, we delivered a novel, first-to-market product in an unmet medical need in 2011 - the first in the company's history.

Opportunities for taking on new and/or additional responsibilities, in addition to advancement, are a key element in our culture. Add to that a science-based, fast-paced work environment and you’ve got an exciting company in which to work.

In addition to opportunities for growth, we offer an outstanding benefits andcompensation package to help meet personal needs as well.

Take a look at our current openings to find the match that’s right for you!

Incyte Corporation values the talents of our diverse workforce and is proud to be an Equal Opportunity Employer.


Director Commercial QA Compliance, EU/EEA Qualified Person

Department: Global Quality Assurance
Location: Incyte Biosciences Technical Operations Distribution B.V.

Director Commercial QA Compliance, EU/EEA Qualified Person 

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% 

We Respect Your Privacy 

Learn more at: http://www.incyte.com/privacy-policy 

The Incyte hiring organisation processes your personal data to manage your job application in order to enter into an employment contract with you if you are the successful candidate. 

During the process, you may be asked to respond to some questions that will screen your application out if you do not meet certain objective criteria required by the job.   You can learn more about this process here 

You have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.  

You can learn more about Incyte’s data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte’s data protection officer, and your supervisory authority. 

Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.

Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.

  

Applicant Tracking System Powered by ClearCompany HRM Applicant Tracking System