Job Opportunities in Switzerland

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Job Description

About the role:

An exciting and challenging opportunity has become available at Takeda Neuchâtel Plant (approx. 670 employees) for a Quality Manager, within the Quality Assurance Department.

This is an exciting career opportunity for a dynamic, autonomous, continuous improvement minded and change agile professional to embrace a team-based culture and more specifically within the Quality Unit team within a world-class Biotech manufacturing environment.

The scope of the role is to manage the day-to-day and the medium to long-term operations related to Quality Control and Raw Material activities related to sterile biologic products manufacturing, ensuring compliance with the license, regulations as well as c GMP Regulations. He/she will manage and develop his/her team to contribute to their career growth. The job holder is expected to act as Qualified Person Delegate.

How you will contribute:

• Ensures the day-to-day quality oversight of the Quality Control activities and Raw Material management related to his/her scope of responsibility
  
• Ensures raw material release and manages specifications
  
• Collaborates with suppliers to address quality issues and implement corrective action plans
  
• Responsible for the effective management of the quality systems operating in his/her scope, including deviations (events), CAPA, batch review, change control, documentation, etc. Effectiveness is demonstrated through KPIs and management reviews in line with Site Guidance.
  
• Supports the Quality on the Shop Floor culture
  
• Provides direction in the event of manufacturing incidents that may potentially affect quality or compliance
  
• Ensures that deviations and complaints are investigated, reports are available
  
• Ensures that escalation mechanisms as defined in site regulations are being adhered to
  
• Supervises ongoing daily departmental activities for areas of direct responsibility, and when required assist other areas in the successful performance of these activities.
  
• Ensures a constant alignment with his/her QA peers to provide a consistent quality support to the entire Neuchâtel site and beyond
  
• Cultivates a smooth and collaborative partnership with his/her local and global business partners (i.e., Laboratories, Supply Chain, Manufacturing)
  
• Contributes to site strategic projects and objectives
  
• Contributes that responses to Regulatory and Compliance requests (RA questions and submissions, Observations, Compliance gaps, Audits, etc.) related to his/her group are provided in a timely manner and with appropriate level of quality
  
• Represents area of responsibility internally and externally
  
• Acts as QP delegate and perform all related activities including batch disposition
  
• Manages a team of about 10 people and conduct Compensation reviews, Performance Review Conversations, Setting of Objectives, Development Plans
  
• Manages the resources to ensure medium to long-term partmental objectives and time scales are achieved
  
• Owns personal accountability for all EHS Aspects, ensuring his/her team is operating in a safe workplace
  
• Drives continuous improvement and Lean Culture
  

What you bring to Takeda:

• University degree in Life Science
  
• Minimum 5-10 years of experience in sterile and/or biological products pharmaceutical industry with extensive experience in Quality Control operations
  
• At least 5 years of experience in people management
  
• Good knowledges of method validation/verification and equipment/software validation requirements
  
• Excellent knowledge of c GMP/GLP
  
• Experience of aseptic filling under isolator and of visual inspection is highly appreciated
  
• Qualified Person/delegate experience is a plus
  
• Fluent English (C1) and French (min B2) is a must
  

Locations

CHE - Neuchatel

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time