Quality System ExpertApply Now Email Me Job ID SR0029145 Date posted 01/08/2019 Location:Neuchâtel, Switzerland
The Quality System Expert is responsible for supporting the Quality and Regulatory Compliance group from a Subject Matter Expert (SME) standpoint in accordance with Takeda policies, standards, procedures and Global cGMP. The Quality System Expert insures that new or modified Quality Systems (deviations, change controls, quality risk management, complaints …) are readily implemented on site and insures that existing systems conform to internal and external quality standards. He/She is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient safety and meeting business needs. He/She provides quality oversight and quality assurance (QA) support to partners (QA, manufacturing, projects). He/She actively participates to internal and external inspections. Responsibilities Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process. Prepare oral and written communications and communicate problems to management with clarity and accuracy Ensures appropriate deployment and coordination with global and within the site of the Quality Systems Acts as Subject Matter Expert of one of the Quality Systems and support the others and he/she monitors his/her quality system performance for emerging trends and search for improvement opportunities. Acts as Quality approver as appropriate Support the preparation of the inspections including the pre-requested documentation, and contribute to the definition of the strategy of the observation answers, in their development, and plans for corrective and preventive action, and follow completion of CAPAs Participate to the audit team as appropriate Support the regular monitoring and the update of the Compliance Readiness Plan of the site with the different services Support the preparation and the analysis of the indicators related to the compliance activity and propose improvement actions in case of indicators showing underperformance Support Quality Assurance Experts and Quality Product Experts in bringing Compliance support or acts as Quality representative in projects. Provides Compliance coaching and training to partners Deliver training which he/she is in charge, Participate to the deployment of the QMS simplification/integration Qualifications: Bachelor level degree in life technology fields (i.e. biotechnology, (bio)chemistry, engineering); advanced degree preferred 5+ years experience with at least 3 years with cGMP manufacturing, Quality, and Compliance and demonstrated use of Quality tools/methodologies Ability to understand aseptic manufacturing processes Ability to work in a highly matrixed and geographically diverse business environment. Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects (project management). Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail. French and English level B2 or higher are a must Living our leadership behaviors is a basic expectation for all Takeda employees. Takeda expects all employees to embody the following: Be Positive Be Accountable Be Results Oriented Be An Excellent Manager of Self and Others
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