Apply Now

Senior Director, Quality Assurance Bioplant

Yverdon, Switzerland | Incyte Corporation

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
  • Functions:
    General Management
    Quality Assurance
  • Experience:
    12-15 years
Job Description:
99 people have viewed this job


This is a leadership role responsible to manage the Quality assurance activities of the new bio-manufacturing plant in line with cGMP regulations for clinical and commercial supply of biological API. The position will ensure Quality operational compliance to Incyte and Regulatory standards.

This position will manage Incyte’s bioplant Quality Assurance group.

The incumbent will act as the Responsible Person of Incyte Biosciences Technical Operations Sàrl, in accordance with articles 5, 10, 14 and 15 of the Swiss Ordinance on Establishment Licenses.

During the initial phase of the site construction and startup this position will be responsible to ensure the site GMP readiness in preparation of the first GMP manufacturing operations and of the site GMP certification by regulatory Authorities.

In addition, this position is accountable to establish, organize and maintain the site Quality Management System of the bioplant in order to comply with Incyte’s corporate system and applicable regulatory requirements.

The Senior Director, Head of Quality Assurance will be a member of the company Quality Leadership Team.


Primary Responsibilities:

During the Site initiation phase:

Responsibilities will include ensuring that the qualification and validation activities 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 meet the quality standards, cGMP, EU/US regulations.

Lead the site GMP readiness program

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 (i.e. test protocols, CAPAs, deviations, change controls, technical documentation)

Prepare regular status updates for reporting progress, issues as it relates to Quality and cGMP compliance to project Management

Lead and manage the site Quality Assurance team

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

Be the main point of contact for all quality compliance key topics

Prepare the site for regulatory inspections (Swissmedic and International)

Be the primary contact with Swissmedic for the site GMP certification process

During the operational phase:

Ensure that all regulatory licenses and registrations are kept current

Ensure all governing procedures are in place and current with regulations and company policies and standards

Manage the day to day Quality operations including deviations, change controls, complaints, batch record review, product and material disposition

Drive resolution of internal and external serious quality issues and escalate to Sr Management;

Develop and implement the site Quality Management Review program including compliance 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

Oversee tech transfer, method transfer and Validation activities

Organize and lead quality improvement projects and teams

Chair the Site Quality Management Reviews

Lead, motivate and develop on-going competencies of a team of Quality professionals

Effectively organize QA resources to support long term business growth in line with Incyte’s requirements and external regulations and standards.

Ensure Inspection readiness programs are in place and lead applicable regulatory inspections.

Implement a robust Quality Risk Management program

Ensure GxP audit programs are developed, implemented and monitored.

Ensure GxP Quality Technical Agreements are in place and maintained

Stay current with the applicable regulations and promote Quality across the Incyte organization


Must be fluent in French and English (the company language)

Firsthand experience of minimum 12 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

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.

Contribute positively to a strong culture of business integrity and ethics

Act within compliance and legal requirements as well as within company guidelines


Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering);

Advanced degree strongly preferred with experience in Biotechnology

Other companies hiring with Ivy Exec

 Company Logos