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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.


Manager, Quality Management

Department: Global Quality Assurance
Location: Incyte Biosciences Technical Operations Sŕrl - Morges

SUMMARY

This position reports to the Global Commercial QA function and is responsible to manage Quality Systems related to the GMP operations for commercial Products, in accordance with Incyte Standards and Regulatory Requirements.

He/She will also act as primary user support for electronic systems for Documentation (eDMS), Training (eLMS) and Quality Processes (eQMS) management for European based employees.

DUTIES AND RESPONSABILITIES

  • Quality Management

    • Collect and issue compliance and QA performance Metrics supporting Functional and Global Quality Management Reviews

    • Lead periodic reviews of the Change control, deviations, CAPA and audit system to ensure continuous compliance and identify trends and follow-up actions

    • Manage the Quality Plans pertaining to Commercial QA and ensure completion of commitments

    • Develop and Maintain the list of approved Commercial GMP/GDP Vendors

    • Develop and Maintain the Commercial QA external audit plan

    • Manage the SOP and Technical Quality Agreement periodic review program for Commercial QA

    • Author SOPs

    • Support the Company Global GMP/GDP Training Program by defining Training requirements applicable to Commercial GMP and conducting SOPs classroom trainings and

    • Provide support for regulatory agency inspections including retrieving requested files, documents or generating reports from the Incyte eDMS and LMS and eQMS.

  • Electronic system primary user support for European based employees:

    • Provide end user initial and periodic training on e-systems

    • Develop and configure metrics Dashboards

    • Be the point of contact for first level QA system support

    • Manage e-systems Master data

    • Assist with the configuration, testing and validation of Incyte’s e-systems

    • Partner with the Incyte e-systems super user community to develop user instructions, recommend configuration or process improvements

    • Collaborate with Global Quality Management System and Systems Administrator.

  • Documentation Control:

    • Perform QC check of controlled documents before approval

    • Track the internal routing of GxP controlled documents, assuring proper and timely review, approval and effective dating.

    • Manage and track controlled document distributions to external Incyte partners.

    • Maintain proper filing and storage practices

REQUIREMENTS

  • Master’s degree, preferably in a scientific discipline or in Quality Management.
  • At least 5 years of experience within a Quality Assurance Department in the pharmaceutical industry and ideally 2 years in a similar Quality Management role
  • Strong attention to details and to compliance
  • Ability to collect, analyse and report complex information
  • Excellent interpersonal skills and ability to interact effectively with multidisciplinary teams while promoting Quality and GxP Compliance
  • Good Communication skills
  • Customer oriented mindset
  • Good understanding of the Pharmaceutical business
  • Ability to plan, prioritize, and execute multiple parallel projects;

 

We Respect Your Privacy

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

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

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

You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may 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 (if applicable).

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

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