Senior Director, Head of Bioplant Quality Assurance
Incyte Corporation
Lausanne,
vor 2 Tg.

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 Incyte’s 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

Bachelor’s 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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