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
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.
Bachelor’s Degree in relevant field such as Chemical Engineering, Bio-engineering, Bioprocessing
Advanced degree strongly preferred
Experience in the biotechnology / pharmaceutical production