Quality Systems Manager

工作内容

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Job Description

Primary duties

• ensure that the Quality System processes are effectively established, maintained and improved
• manage through the site Systems Execution Leads the coordination of the Quality Systems activities including the Deviation, Change Control, Documentation, GMP training and Laboratory Information Management processes and systems.
  
  

Responsibilities

• Manage the execution and maintenance of
  
  • the Deviation Process. Ensures that deviations, associated investigations and action plans are appropriately and timely performed and documented.
  • the Change Control Process. Ensures Changes are appropriately documented and timely implemented.
  • the Documentation Process.
  • The GMP training quality oversight
  • Laboratory Information Management System (LIMS)
  • administration access role of analytical equipment’s.
• Responsible for ensuring compliance with all applicable provisions of the Takeda Quality Management System, the regulations and standards applicable to the operations.
• Conduct gap analyses, implement Quality Management System procedures in departments and manage compliance.
• Understand and assure conformance to applicable Takeda standards and regulations. Interface with regulators during inspections.
• Define and manage action plans to ensure satisfactory quality metrics
• Establish goals for the Quality Systems department in alignment with the global and site strategy, and take action as needed to ensure timely delivery of goals.
• Responsible for the coaching, training, and development of the Quality Systems team.
• Ensure an adequate Training and Qualification program is in place
  
  

Education And Experience Requirements

• Bachelor’s – Master’s degree in engineering, chemistry, biology or related discipline
• At least 5 years’ experience in Quality or related field in the pharmaceutical industry.
• At least 5 years of leadership experience, developing people and strength in managing projects and initiatives
• A thorough understanding of pharmaceutical quality management systems and regulations including current GMPs & GDDPs. Experience working with regulatory agencies and/or direct interface experience with regulatory agencies during inspections preferred.
  
  

Key Skills, Abilities, And Competencies

• Fluent in written and spoken French and English
• Personal accountability for results and integrity. Critical thinking, analytical, deal with ambiguity and problem solving skills.
• Demonstrated ability to work autonomously and to take decisions
• Organizational and ability to innovate, lead change, deliver strong results and build the confidence as well as trust of stakeholders.
• Experience with Continuous Improvement initiatives
• Ability to lead multidisciplinary and multi-site projects
• Strong oral and written communication skills and ability to communicate with all levels of management, peers, contractors and external partners effectively
• Strong organizational skills
• PC skills and be competent in Word, Excel, PowerPoint and SharePoint
  
  

Locations

BEL - Lessines

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time