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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.

Quality System Manager

Department: Quality Assurance and Control
Location: Incyte Biosciences Technical Operations SÓrl - Yverdon

Job Summary  (Primary function)

This position is responsible to leads the Quality Assurance System activities of the new large scale API bio-manufacturing facility in line with applicable regulatory requirements. 
Responsibilities will include implementation of new local quality system procedures required for operation of biopharmaceutical drug substance manufacturing according to quality policies, cGMP, Swiss, EU / US FDA Regulations. More specifically this position will establish and lead in the new production facility the following quality assurance systems: training, documentation, change control, CAPAs, deviation management, risk management, supplier qualification, internal and external audits.

Essential Functions of the Job  (Key responsibilities)

  • Establish, lead and manage the following Quality Assurance Systems on the new facility: training, documentation, change control, CAPAs, deviation management, risk management, supplier qualification, internal and external audits
  • Work with the project team and the engineering companies on the quality assurance requirements and ensure adequate use of quality assurance system during the project
  • Establish SOPs for quality systems management and ensure alignment with global Quality Assurance Systems and requirements
  • Review and approve project quality assurance strategy documentation (Project Quality Plan, Validation master Plan, Project change controls)
  • Ensure compliance of QA systems with cGMP and applicable regulations and lead inspection readiness program
  • Establish, lead and manage the documentation system of the new facility
  • Develop training curricula for new facility organization and provide GMP training modules
  • Implement and manage the deviation, change control and CAPAs management systems
  • Develop a supplier qualification plan and perform audits according to the plan
  • 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

Qualifications (Minimal acceptable level of education, work experience, and competency)

  • Must speak English and French
  • Must have minimum of 8 years in a quality assurance management role in a biopharmaceutical manufacturing environment
  • Thorough knowledge of quality assurance systems with demonstrated experiences in the following systems: training, documentation, change control, CAPAs, deviation management, risk management, supplier qualification, internal and external audits
  • Demonstrated proficiency in good practice requirements GMP as well as biopharmaceutical industry regulations and standards related to quality systems
  • Must have proficiencies with the quality systems and, preferably, with business processes associated with automation and integration of testing and production systems
  • Experience of management or lead of health authorities inspections
  • People management experience
  • The ability to make pragmatic and compliant decisions
  • Strong result orientation and committed team member
  • Flexibility and ability to travel
  • Excellent written and verbal communication skills.
  • Bachelor’s Degree in relevant field such as Pharmacy, Chemistry, Biology or Bioengineering
  • Advanced degree preferred
  • Strong experience of quality assurance systems

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.

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