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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.


Senior Director, Head of Bioplant Quality Assurance

Department: Quality Assurance and Control
Location: Incyte Biosciences International SÓrl VD

 

Summary

Leads and manages the Quality Assurance activities of the bio-manufacturing plant under cGMP regulations for clinical and commercial supply of biological API. Provides leadership, direction and oversight to the associated team.  Responsible to meet financial and quality performance goals.  

Initially, this position will be responsible for the Quality Assurance oversight of the manufacturing activities during the design, construction and startup of a new green-field, large scale manufacturing facility.  Responsibilities will include supporting the qualification and validation during the design development, procurement, factory acceptance testing, installation, commissioning and qualification of new process systems and equipment utilized in the production of biopharmaceutical drug substance according to quality policies, cGMP, EU / US FDA Regulations.  

In addition, this position is accountable to establish, organise and maintain the site Quality System in order to comply with Incyteĺs corporate system and applicable regulatory requirements. 

Primary Responsibilities: 

  • During the Site initiation phase

    • Work with the Engineering company in detail design deliverables

    • Work with the general contractor in detail design deliverables

    • Understand and implement internal policies, procedures and specifications as required for the execution of quality compliance for the project

    • Define the strategy for review and approval of qualification, validation and engineering documents (ie test protocols, CAPAs, deviations, change controls, technical documentation)

    • Prepare regular status updates for reporting progress, issues, safety, quality etc. to project management

    • Lead and manage a team in the quality compliance area

    • Ensure that all SOPs are in place for facilities and equipment qualification / validation

    • Ensure qualification and validation of all equipment in close collaboration with process engineering & automation teams 

    • Act as the main point of contact for all quality compliance key topics

    • Prepare the site for regulatory inspections (Swissmedic and International)

  • During the operational phase

    • Ensure that all licenses and registrations are kept current

    • Ensure all SOPs are in place and current

    • Compile and present plant Quality Metrics

    • Main point of contact with local and international Regulatory Agencies

    • Ensure all products are manufactured and released according to applicable regulations and registered details

    • Organize and lead quality improvement projects and teams

Qualifications

  • Must speak English and French

  • Must have minimum of 10 years in a Quality senior managerial role in a biopharmaceutical manufacturing environment

  • Thorough knowledge of biotechnological technologies, processes and clean utilities

  • Demonstrated proficiency in good practice requirements GMP as well as biopharmaceutical industry regulations and standards related to qualification and validation

  • Must have proficiencies with the quality systems and, preferably, with business processes associated with automation and integration of testing and production systems

  • The ability to make pragmatic and compliant decisions

  • Strong result orientation, excellent team leader as well as committed team member

  • Flexibility and ability to travel

  • Excellent written and verbal communication skills.

Education

  • Bachelorĺs Degree in relevant field such as Chemical Engineering, Bio-engineering, Bioprocessing

  • Advanced degree strongly preferred

  • Experience in the biotechnology/pharmaceutical production

 

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