Aperçu
With a reporting line in the Quality Assurance team, this position leads the daily Quality System activities and related operations associated with the development and the maintenance of a Quality Management System for Incyte manufacturing facility in Switzerland. Responsibilities include the monitoring of site compliance, the management of core quality processes and administration of electronic quality management systems, including documentation and training, according to quality policies, cGMP and applicable regulations.
DUTIES AND RESPONSIBILITIES
* Monitor the Bioplant quality compliance.
* Identify and elevate risk areas.
* Prepare the QMR data and chair the meeting.
* Represent Bioplant QA in Global Quality systems initiatives.
* Participate in or lead continuous improvement projects, welcoming diverse perspectives and inclusive collaboration.
* Lead the Bioplant Quality champion community across all departments.
* Lead the daily eQuality System administration for the Bioplant.
* Manage the assigned core quality processes:
o Quality management review
o Documentation, archiving & training
o Deviation & CAPA
o Change Control
* Lead inspection backrooms and act as scribe when required.
* Act as Primary site SME for assigned core Quality processes.
* Manage the QA System team related to QS activities (i.e. documentation archiving, onboarding of new hires, training maintenance, users support, QMS training).
* Manage and organize the activities to ensure compliance use of QMS.
* Act as Quality Champion for the Bioplant QA department to drive a high level of quality in the department:
o Monitor and report quality compliance indicators for QA department
o Chair Quality compliance reviews in the department
o Implement quality compliance initiatives in the department in collaboration with QA and the bioplant quality champion community
o Coach and support other team members for quality compliance matters (such as deviation and changes management)
o Coordinate the department inspection readiness
* Act as a primary site SME for Artificial Intelligence projects related to Quality Systems.
* Participate in internal audits and Gemba.
* Act as QA approver for document changes, deviation, CAPA.
* Drive resolution of major quality issues.
* At all times work in a right first time and site inspection readiness approach.
* 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.
* QA representative for IA topics.
QUALIFICATION
* Bachelor’s Degree in relevant field such as Pharmacy, Chemistry, Biology or Bio-engineering.
* Relevant years of experience in Quality Assurance in a GMP environment.
* Proficiency with electronic Quality System administration. Advanced expertise in good practice requirements GMP as well as biopharmaceutical industry regulations and standards with Quality Systems.
* Experience in health authorities inspections.
* Ability to exercise quality decisions in a pragmatic and compliant fashion.
* Strong result orientation and committed team member.
* Must speak, read & write in both English and French.
* Excellent written and verbal communication skills.
DELEGATION
The position can delegate tasks and duties relative to Quality Systems to Quality Associate Directors.
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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