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Incyte · Yverdon-les-Bains, Switzerland

# Specialist Quality System

Yverdon-les-Bains, Switzerland Manufacturing & Production 

Listed on Incyte’s official careers site. Posted September 16, 2026. Check that it is still open and apply there.
[Apply on Incyte’s careers site →](https://careers-incyte-ita.icims.com/jobs/6527/login)

[OpenNash Jobs](https://jobs.opennash.com/) / [Incyte](https://jobs.opennash.com/companies/incyte/) / Specialist Quality System

## Job description

### SUMMARY

With a reporting line in the Quality Assurance team, this position supports the Quality System activities and related operations associated with the maintenance of a Quality Management System for our large scale API bio-manufacturing facility. Responsibilities include supporting the management and maintenance of Quality Management Systems according to quality policies, cGMP, Swiss, EU / US FDA Regulations. More specifically this position will participate to the improvement, maintenance and application of the following QA processes: Training, Documentation (including controlled copy & logbook management), GXP Personnel management, Retention/Archiving, deviation & Change control.

### DUTIES

AND RESPONSABILITIES
- Act as a QA Admin and SME on eDMS and eQMS including Documentation, Retention/Archiving, Training, deviation & change control processes
- Train users on documentation Management and Training systems, and support other training where necessary
- Support actively system users in their daily tasks within the different quality systems
- Act as key contact point for users at the Bioplant for specific troubleshooting. Escalate unresolved topics to Global QMS team when necessary
- Manage the documentation change control process and Release Bioplant documentation and associated training
- Maintain local training matrix and assign training within the e-DMS
- Support Bioplant departments in the training strategy definition and maintenance
- Responsible for local GMP documents filing and archiving system
- Archive department paper document internally and be the point of contact for external archiving
- Issue / reconciled controlled copies & monitor them with department
- Ensure employees onboarding on the different Quality Systems, Welcome Day and delivery-related training
- Maintain employee’s initials and personnel onboarding/termination up to date
- Develop training materials & deliver QMS training to users regarding the different Quality Systems (including but not limited to: Good documentation practices, cGMP, Document owner or viewer within the eDMS, etc…)
- Drive continuous improvement of all QS processes
- Prepare and maintain site Dashboards
- Prepare KPIs extract and metrics follow-up to monitor Quality systems health and compliance with cGMP and internal applicable documents (including QMR metrics)
- Participate to internal audits
- Act as QA approver or SME when necessary on changes, deviation, CAPA
- Participate, and lead when identified, QA Systems improvements projects
- Participate to inspection preparation, logistic and presentation
- At all times work in view of the site readiness for regulatory inspections (Swissmedic and International)
- Contribute positively to a strong culture of business integrity and ethics
- Act within compliance and legal requirements as well as within company guidelines Delegate to: QA Specialist, QA Manager

### REQUIREMENTS

Qualification:
- Must speak, read & write in both

### English and French
- Must have 2 year of experience in a GMP environment including the use of e-systems (Biotech, pharmaceutical or equivalent industries)
- Good understanding of basic GMP requirements related to Quality system activities (biopharmaceutical industry regulations and standards with Quality Systems) is a plus
- Good Knowledge on quality system software (Veeva is a plus)
- Experience in health authorities inspections is a plus
- Ability to make pragmatic and compliant decisions
- Strong result orientation and committed team member

### Excellent written and verbal communication skills Education
- Bachelor’s Degree in relevant field such as Pharmacy, Chemistry, Biology or Bio-engineering, Bioprocessing is a plus

### Trainer and/or auditor certification is a plus 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.

### We Respect Your Privacy Learn more at

[http://www.incyte.com/privacy-policy](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.

## At a glance
- Posted by the employer: Sep 16, 2026
- First seen by OpenNash: Oct 20, 2026
- Last checked: Oct 20, 2026
- Listed for: 34 days
- Location: Yverdon-les-Bains, Switzerland[Apply on Incyte’s careers site →](https://careers-incyte-ita.icims.com/jobs/6527/login)

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