Senior Director, Quality Assurance Bioplant
Yverdon, Switzerland | Incyte Corporation
Industry:Pharmaceutical / Biotech
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.
DUTIES AND RESPONSABILITIES
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
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